Anumana Receives FDA 510(k) Clearance on ECG-AI™ LEF for Early Detection of Low EF

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WSJ: One project—with the Mayo Clinic and a health-technology company called Anumana based in Cambridge, Mass.—aims to speed up diagnosis of high blood pressure in the lungs, or pulmonary hypertension. It now can take two or more years to identify the life-threatening disease.

J&J Hired Thousands of Data Scientists. Will The Strategy Pay Off?

Coherent Market Insights: The global electrophysiology devices market is expected to exhibit a CAGR of 12.6% during the forecast period due to the increasing organic strategies such as acquisition by the key market players. For instance, in November 2022, anumana, Inc., a health technology company, announced that they had acquired NeuTrace, a medical technology company. This acquisition will help anumana, Inc., for the development of electrophysiology platform.

Global Electrophysiology Devices Market to Surpass US$ 20,069.2 Million by 2030, Says Coherent Market Insights (CMI)

Pharma Times: Artificial intelligence (AI) health technology company, Anumana, will collaborate with Pfizer to develop an artificial intelligence electrocardiogram algorithm (AI-ECG), which enables the early detection of cardiac amyloidosis.

Pfizer and Anumana boost detection of cardiovascular disease

Bioworld: Anumana Inc. has garnered a U.S. FDA breakthrough device designation for its artificial intelligence (AI)-powered electrocardiogram-based algorithm for early identification of cardiac amyloidosis. The ECG-AI detection algorithm is the fourth from the company and its partners to notch breakthrough status.

Anumana’s AI algorithm for cardiac amyloidosis gets FDA breakthrough nod

Developed in collaboration with Janssen and Mayo Clinic, this technology has the potential to aid physicians in earlier detection of pulmonary hypertension, a progressive, life-threatening disease

CAMBRIDGE, Mass., May 24, 2022 – Anumana, Inc., an AI-driven health technology company from nference, Inc., today announced that the U.S. Food & Drug Administration (FDA) has granted Breakthrough Device Designation to its AI-enhanced, ECG-based Pulmonary Hypertension (PH) Early Detection Algorithm. The algorithm is a precise, non-invasive screening tool that addresses an unmet need for earlier diagnosis of patients with pulmonary hypertension, which may otherwise go unnoticed until the disease has advanced, delaying treatment initiation, thereby limiting treatment efficacy and adversely impacting patient outcomes.

FDA Breakthrough Device Designation recognizes novel innovations that demonstrate the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases and helps to accelerate the regulatory process.

“Electrophysiology waveforms hold immense untapped potential for detecting diseases earlier in their natural history, particularly for conditions in which earlier diagnosis and therapeutic intervention can prolong survival and improve quality of life,” said Venky Soundararajan, PhD, co-founder and Chief Scientific Officer of Anumana and nference. “The FDA's Breakthrough Device Designation for Anumana's PH Early Detection Algorithm is one step forward for the field of ECG AI overall, and more saliently, a giant leap forward for PH patients.”

PH is a progressive, life-threatening disease estimated to affect up to 0.1-1% of the global population.1,2 Due to the non-specific symptoms of the disease, such as shortness of breath, diagnostic delays are common3,4,5, often longer than a year, and have been linked with a higher mortality risk in certain patient subgroups.6,7

Anumana’s AI-enhanced ECG algorithm is designed to easily and safely detect PH at an earlier stage, by leveraging the widespread availability of 12-lead ECGs in primary care, urgent care, and emergency room settings. The AI-enhanced ECG PH Algorithm is enabled by the nference platform, which provides insight from more than 6 million de-identified patient records, including over 8 million ECGs. It was developed through a collaboration between data scientists and physicians at Anumana, Janssen Research & Development, LLC, and Mayo Clinic. Supported by Mayo Clinic Platform, nference launched Anumana in 2021 to develop and commercialize AI-enabled algorithms.

If approved, the early detection algorithm will be offered as Software as a Medical Device (SaMD) that can be downloaded on a physician’s smartphone, tablet, or computer, or accessed via the Cloud through an Electronic Health Record or ECG Information Management System interface. Using a standard 12-lead ECG, the algorithm analyzes the voltage-time data and within seconds provides a prediction of likelihood of PH, reducing the time between initial symptoms and the first evaluation for PH via targeted cardiac imaging. This early detection algorithm is still in development and not yet approved for clinical use.
 
“While therapeutic options for patients with pulmonary hypertension have evolved in recent years, we have not seen significant advancement in reducing the time from symptom onset to diagnosis – and our hypothesis was that data science could help change this,” said Najat Khan, PhD, Chief Data Science Officer and Global Head, Strategy and Operations, Janssen Research & Development, LLC. “We leveraged the power of artificial intelligence, the ingenuity of our data scientists and researchers, and deep collaboration to co-develop this AI-based innovation, with the ultimate goal of helping to improve patient outcomes and transform the trajectory of this devastating disease.”
 
“Early diagnosis of pulmonary hypertension is paramount due to its progression and potential severity,” said Paul Friedman, M.D., chair of the Department of Cardiovascular Medicine at Mayo Clinic. “The addition of AI to a standard ECG – a painless, inexpensive, widely used test that is routinely performed – transforms the ECG into a screening tool for PH, with the opportunity to improve outcomes via early detection by guiding appropriate testing.”

The Pulmonary Hypertension Early Detection Algorithm is the company’s second technology to receive FDA Breakthrough Device Designation. Its low ejection fraction algorithm, developed by Mayo Clinic and licensed by Anumana, received Breakthrough Device Designation in 2019 and Emergency Use Authorization for COVID-19 in 2020. Anumana has a large pipeline of novel algorithms that have been validated by over 30 peer-reviewed publications, including a first of its kind prospective clinical impact study on low ejection fraction that was published in Nature Medicine in 2021. These software solutions are currently in development with each algorithm as a candidate for FDA medical device approval.

About Anumana
Anumana, an AI-driven health technology company and a portfolio company of nference and Mayo Clinic Platform, is harnessing industry-leading AI and translational science to decode the electrocardiogram as never before – as a deep predictive tool and biomarker of disease – empowering care providers to help patients early. Anumana algorithms have been developed, trained, and validated using clinical data from Mayo Clinic, and are undergoing rigorous clinical trial validation. Anumana is developing AI-enabled ECG algorithms for real-world physician use, integrating point-of-care applications into existing workflows, thereby reducing costs, improving outcomes, and enhancing quality of life. Anumana’s AI-enabled tools can diagnose hidden conditions earlier than ever before. Anumana’s algorithms are investigational medical devices and have not yet received regulatory approval or clearance. For more information, visit anumana.ai and follow Anumana on LinkedIn & Twitter.

About nference
Through its powerful technology platform and software, nference is transforming health care by making biomedical knowledge computable. Its partnership with Mayo Clinic has given nference an opportunity to synthesize more than 100 years of institutional knowledge, producing real-world evidence in real time by converting large amounts of data into deep insights to advance discovery and development of diagnostics and therapeutics. nference is headquartered in Cambridge, Mass. Follow nference on LinkedIn and Twitter. Visit us at nference.com.

Andrea Sampson, Sampson Public Relations Group

Wijeratne DT, Lajkosz K, Brogly SB, et al. Increasing Incidence and Prevalence of World Health Organization Groups 1 to 4 Pulmonary Hypertension. Circ Cardiovasc Qual Outcomes. 2018;11(2):e003973. doi:10.1161/CIRCOUTCOMES.117.003973

Hoeper MM, Humbert M, Souza R, et al. A global view of pulmonary hypertension. Lancet Respir Med. 2016;4(4):306-322. doi:10.1016/S2213-2600(15)00543-3

Armstrong I, Billings C, Kiely DG, et al. The patient experience of pulmonary hypertension: a large cross-sectional study of UK patients. BMC Pulm Med 2019: 19: 67.

Brown LM, Chen H, Halpern S, et al. Delay in recognition of pulmonary arterial hypertension: factors identified from the REVEAL Registry. Chest 2011: 140: 19-26.

Rich S, Dantzker DR, Ayres SM, et al. Primary pulmonary hypertension. A national prospective study. Ann Intern Med 1987: 107: 216-223.

Khou V, Anderson JJ, Strange G, et al. Diagnostic delay in pulmonary arterial hypertension: Insights from the Australian and New Zealand pulmonary hypertension registry. Respirol Carlton Vic. 2020;25(8):863-871. doi:10.1111/resp.13768

Klok FA, Barco S, Konstantinides SV, et al. Determinants of diagnostic delay in chronic thromboembolic pulmonary hypertension: results from the European CTEPH Registry. Eur Respir J. 2018;52(6):1801687. doi:10.1183/13993003.01687-2018

FDA Grants Breakthrough Device Designation to Anumana’s ECG Pulmonary Hypertension Early Detection AI Algorithm

Health Evolution: Researchers in Future Healthcare Journal say that while there are claims from organizations that they’ve developed an AI solution that can “diagnose and treat a disease with equal or greater accuracy than human clinicians,” most of them are based on radiological image analysis. A survey of health care leaders found that while 58 percent are using AI in clinical practice, the most common applications are all related to imaging. 

Promising AI clinical use cases beyond imaging

IMC Newsdesk: Mayo Clinic has developed health technology to deliver clinical decision support tools, diagnostic insights and care recommendations so clinicians can make faster and more accurate diagnoses and provide continuous care to patients.

Mayo Clinic platform aids clinical decisions

Mayo Clinic News Network: Two health tech advances are at the heart of a study published in Nature Medicine: an app and backend infrastructure to let patients remotely share smartwatch ECG data with their clinicians in an easy and secure way, and the modification of a proven 12-lead ECG artificial intelligence (AI) algorithm to enable it to run on a single-lead watch ECG recording.

AI transforms smartwatch ECG signals into a diagnostic tool for heart failure

AZO Robotics: The EAGLE—short for ECG AI-Guided Screening for Low Ejection Fraction—trial attempted to establish whether an artificial intelligence (AI) screening tool designed to spot low ejection fraction through EKG data could enhance the diagnosis of this medical disorder in regular practice. The results of the study have been published in the Nature Medicine journal.

New Study Demonstrates Value of AI-Enabled EKG Algorithm in Routine Practice

EurekAlert: Heart disease can take a number of forms, but some types of heart disease, such as asymptomatic low ejection fraction, can be hard to recognize, especially in the early stages when treatment would be most effective. The ECG AI-Guided Screening for Low Ejection Fraction, or EAGLE, trial set out to determine whether an artificial intelligence (AI) screening tool developed to detect low ejection fraction using data from an EKG could improve the diagnosis of this condition in routine practice. Study findings are published in Nature Medicine.

Trial demonstrates early AI-guided detection of heart disease in routine practice

DotMed: Mayo Clinic has launched two new companies to support its new technology initiative, the Remote Diagnostics and Management Platform. The solution applies artificial intelligence to derive insights from data and uses these findings to support human decision-making within existing clinical workflows. It supports “event-driven medicine” by aiming to provide insights in the right context at the right time.

Pharma File: Anumana has announced the FDA had granted breakthrough Device Designation to its AI-enhanced ECG-based Pulmonary Hypertension (PH) Early Detection Algorithm. Breakthrough Device Designations recognise novel innovations demonstrating potential to provide more effective treatment, or diagnosis for life-threatening or irreversibly debilitating diseases. The designation helps to accelerate the regulatory process.

FDA grants Breakthrough Device Designation to pulmonary hypertension early detection AI

Medical Xpress: Patients with migraine with aura (MwA) have significantly higher artificial intelligence-enabled electrocardiogram (AI-ECG) atrial fibrillation (AF) prediction model output, according to a study from Mayo Clinic published online June 8 in Headache. The study used Mayo Clinic developed algorithm for detecting atrial fibrillation, which is now licensed to Anumana. 

Migraine with aura identified as independent risk factor for A-fib

Medical Product Outsourcing: Artificial intelligence (AI)-driven healthtech company, Anumana has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its AI-enhanced, ECG-based pulmonary hypertension (PH) early detection algorithm. The precise and non-invasive screening tool supports earlier PH diagnosis, which may otherwise not be noticed until the disease has advanced, delaying treatment and limiting efficacy while adversely impacting outcomes.

Anumana's ECG Pulmonary Hypertension AI Algorithm Gains Breakthrough Status

Mobi Health News: Anumana, a joint venture between EHR data company nference and the Mayo Clinic, entered into a multiyear partnership with Pfizer to develop an AI-based tool for the early detection of cardiac amyloidosis. Under the agreement, Anumana will research and pursue FDA De Novo classification for an algorithm that could find signals within electrocardiograms (ECGs) that hint at the condition. The partners also aim to gain regulatory clearance in Europe and Japan.

Pfizer, Anumana team up to develop AI algorithm for cardiac amyloidosis detection

BioSpace: Anumana, Inc., an AI-driven health technology company and portfolio company of nference, has entered into a multi-year agreement with Pfizer Inc. for Anumana to develop an artificial intelligence electrocardiogram algorithm (AI-ECG) designed to enable the early suspicion of cardiac amyloidosis. Anumana will conduct a clinical validation trial and pursue De Novo classification for the algorithm as a Software-as-a-Medical-Device (SaMD) and aims to gain regulatory approval for the algorithm as an SaMD for the detection of cardiac amyloidosis in the U.S., Europe, and Japan.

Anumana and Pfizer Partner to Enable Early Detection of Underdiagnosed Cardiovascular Disease

Cardiovascular Business: Anumana, a Massachusetts-based healthcare technology company focused on artificial intelligence (AI), has announced a new multi-year deal with Pfizer focused on improving the identification and diagnosis of cardiac amyloidosis. The groups will work to develop a new AI algorithm capable of identifying signs of cardiac amyloidosis—a significant heart issue that can lead to heart failure—in electrocardiogram (ECG) results.

AI specialists ink deal with Pfizer to target cardiac amyloidosis

Medtech Dive: Anumana, a health technology startup spun out of Mayo Clinic, entered a multi-year agreement with Pfizer to develop an algorithm to detect cardiac amyloidosis, a serious heart condition. Anumana plans to conduct a clinical trial validating the algorithm and seek de novo clearance in the U.S. It also will seek regulatory approval in Europe and Japan.

Pfizer to partner with Mayo Clinic spinoff on early cardiac amyloidosis detection

HIT Consultant: Anumana, an AI-driven health technology company and portfolio company of nference, today announced a multi-year agreement with Pfizer for Anumana to develop an investigational artificial intelligence electrocardiogram algorithm (AI-ECG) designed to enable the early identification of patients who may be at risk of cardiac amyloidosis.

Anumana & Pfizer Partner on Amyloidosis AI-ECG Algorithm Development

Health Leaders: A start-up from the Mayo Clinic orbit is partnering with Pfizer to develop an AI-enhanced ECG that can detect cardiac amyloidosis, a progressive disease that's difficult to diagnose early.

New Project Trains AI on a Hard-to-Diagnose Cardiac Issue

NS Medical Devices: The research agreement with Pfizer will aid Anumana to develop an AI-enabled ECG algorithm to help detect patients who may be at risk of cardiac amyloidosis

Anumana, Pfizer collaborate on AI-based detection of cardiovascular disease

Medical Device Network: Health technology company Anumana and Pfizer have signed a multi-year agreement to develop an artificial intelligence electrocardiogram (AI-ECG) algorithm for the early detection of cardiac amyloidosis. Under the deal, Anumana will carry out a clinical validation trial and seek De Novo classification for the new AI-ECG algorithm as a Software-as-a-Medical-Device (SaMD).

Anumana and Pfizer partner for cardiovascular disease detection

FIERCE Biotech: The heart-focused artificial intelligence company Anumana is looking to break new ground for its algorithms through a partnership with Pfizer. They plan to develop programs that can help diagnose cases of cardiac amyloidosis, where misfolded proteins build up around the tissue. 

Pfizer links up with heart disease AI developer Anumana to build cardiac amyloidosis diagnostics

FDA News: Pfizer has entered into a multi-year deal with Anumana — a joint venture between the Mayo Clinic and nference, an electronic health record data company — to develop software for early detection of cardiac amyloidosis.

Pfizer and Anumana Ink Multi-Year AI Electrocardiogram Algorithm Deal

Diagnostic and Interventional Cardiology: Companies initiate research agreement supporting development of new AI-ECG algorithm to help identify patients who may be at risk of cardiac amyloidosis

Becker's Hospital Review: Pharmaceutical giant Pfizer has partnered with digital health company Anumana, a company founded in 2021 in collaboration with the Mayo Clinic Platform, to develop an artificial intelligence electrocardiogram algorithm used for the detection of cardiac amyloidosis.

Pfizer partners with healthtech company on AI-powered cardiovascular disease detection

Mass Device: Mayo Clinic announced that it is introducing a new technology platform to support two new companies it has launched. Rochester, Minn.–based Mayo Clinic’s Remote Diagnostics & Management Platform (RDMP) is designed to connect data with new AI algorithms and augment human decision-making within existing clinical workflows, according to a news release.

Mayo Clinic helps launch two new companies for improved diagnostics

Innovator News: Mayo Clinic announced a new technology platform and launched two new companies April 14 that promise to improve doctors’ ability to spot disease early by connecting data from remote medical devices with AI-enabled algorithms. The first target is the heart.

New Ventures To Use AI To Target Heart Disease

FIERCE Biotech: Mayo Clinic’s artificial intelligence spinout Anumana is taking a deeper dive into analyzing the pulsing electrical signals of the heart with a new acquisition aimed at developing software used during cardiac procedures.

Mayo Clinic spinout Anumana acquires NeuTrace to develop cardiac procedure AI

Companies initiate research agreement supporting development of new AI-ECG algorithm to help identify patients who may be at risk of cardiac amyloidosis

CAMBRIDGE, Mass. – Dec. 15, 2022 – Anumana, Inc., an AI-driven health technology company and portfolio company of nference, has entered into a multi-year agreement with Pfizer, Inc. for Anumana to develop an artificial intelligence electrocardiogram algorithm (AI-ECG) designed to enable the early suspicion of cardiac amyloidosis. Anumana will conduct a clinical validation trial and pursue De Novo classification for the algorithm as a Software-as-a-Medical-Device (SaMD) and aims to gain regulatory approval for the algorithm as an SaMD for the detection of cardiac amyloidosis in the U.S., Europe and Japan. 

Cardiac amyloidosis is a serious, progressive, and underdiagnosed rare disease that leads to heart failure.1 In patients with cardiac amyloidosis, the heart walls become stiff, making it difficult for the left ventricle to properly relax and fill with blood, while at the same time hampering its ability to squeeze and pump blood out of the heart. Symptoms and comorbidities associated with cardiac amyloidosis, such as shortness of breath, knee pain, bilateral carpal tunnel syndrome, kidney disease, and gastrointestinal issues, can vary and seem unrelated, making diagnosis difficult.2,3 

“The challenge in diagnosing cardiac amyloidosis can prevent patients from getting treatment while the disease continues to progress,” said David McMullin, chief business officer of Anumana. “We believe this collaboration will demonstrate the power of Anumana’s AI-ECG algorithms to help clinicians intervene earlier, giving them greater ability to improve patient outcomes and prolong lives.”

The research agreement with Pfizer will help deepen Anumana’s efforts to implement AI-enabled early detection software that can reveal signals from ECGs that humans cannot interpret. The ubiquitous nature of the painless, non-invasive 100-year-old ECG test gives AI-ECG algorithms the potential to reach a larger number of patients earlier. 

“AI-ECG solutions alert clinicians to humanly imperceptible patterns in ECG signals, providing an early warning for serious occult or impending disease,” said Paul Friedman, M.D., Chair of the Department of Cardiovascular Medicine at Mayo Clinic and Chair of Anumana’s Mayo Clinic Board of Advisors. “This stands to improve the lives of people with cardiac amyloidosis by improving the speed of triage and care of this group.”

Anumana was founded in 2021 in collaboration with the Mayo Clinic Platform. Anumana has licensed Mayo Clinic AI-ECG algorithms for low ejection fraction, pulmonary hypertension, and hyperkalemia, all of which have received Breakthrough Device Designation from the U.S. FDA. These algorithms have been validated by over 75 peer-reviewed publications, including a first of its kind prospective clinical impact study on low ventricular ejection fraction that was published in Nature Medicine in 2021, and another first of its kind batch enrolled prospective clinical impact study that demonstrated the effectiveness of AI-ECG to screen for undetected atrial fibrillation in normal sinus rhythm that was published in The Lancet in 2022.

Anumana, an AI-driven health technology company and portfolio company of nference, is harnessing industry-leading AI and translational science to unlock the electrical language of the heart as never before. Anumana algorithms have been developed, trained, and validated using clinical data from Mayo Clinic and other leading institutions to detect hidden diseases using AI-ECG algorithms and to enhance and improve interventional procedures through real-time AI techniques. Multiple Anumana algorithms have received FDA Breakthrough Device Designation and are currently undergoing rigorous clinical trial validation. Anumana software devices are designed for real-world physician use, integrating into existing workflows at the point of care to reduce costs and enhance quality of life. Anumana algorithms are investigational medical devices and have not yet received regulatory approval or clearance. For more information, visit anumana.ai and follow Anumana on LinkedIn and Twitter.

References
1.     Rapezzi C, Lorenzini M, Longhi S et al. Cardiac amyloidosis: the great pretender. Heart Fail Rev. 2015;20(2):117-124.
2.     Maurer MS, Elliott P, Comenzo R, Semigran M, Rapezzi C. Addressing Common Questions Encountered in the Diagnosis and Management of Cardiac Amyloidosis. Circulation. 2017;135(14):1357-1377.
3.     Ash S, Shorer E, Ramgobin D, Vo M, Gibbons J, Golamari R, Jain R, Jain R. Cardiac amyloidosis-A review of current literature for the practicing physician. Clin Cardiol. 2021 Mar;44(3):322-331.

Media Contact:
Sam Choinski
Pazanga Health Communications for Anumana
schoinski@pazangahealth.com
(860) 301-5058

Becker's Hospital Review: Anumana, a portfolio company of Mayo Clinic Platform, has acquired NeuTrace, a medtech startup that applies artificial intelligence to electrophysiology. Anumana can now integrate a patient's entire EHR with corresponding electrocardiograms and cardiac electrograms.

Mayo Clinic Platform portfolio company buys AI electrophysiology startup

AI Thority: Anumana, an AI-driven health technology company and portfolio company of nference, announced it has acquired NeuTrace, a medical technology company advancing novel in-procedure AI applications for electrophysiology (EP). The acquisition includes the NeuTrace EP Data Biome platform and a portfolio of AI-enabled EP software applications in development. As part of the transaction, nference acquired rights to the Data Biome platform for uses outside of the cardiovascular field.

Anumana Acquires NeuTrace, Establishing a Comprehensive Electrophysiology Deep-Learning Development Platform and Product Pipeline

Anumana acquires NeuTrace, a medical technology company advancing novel in-procedure AI applications for Electrophysiology (EP) 

CAMBRIDGE, Mass., Nov. 7, 2022 – Anumana, an AI-driven health technology company and portfolio company of nference, announced today it has acquired NeuTrace, a medical technology company advancing novel in-procedure AI applications for electrophysiology (EP). The acquisition includes the NeuTrace EP Data Biome platform and a portfolio of AI-enabled EP software applications in development. As part of the transaction, nference acquired rights to the Data Biome platform for uses outside of the cardiovascular field.

The acquisition positions Anumana as a leader in AI medical software development for cardiac electrophysiology, with a combined development capability - powered by nference’s nSights real world evidence generation platform - that can integrate a patient’s entire electronic medical record (EMR) with corresponding electrocardiograms (ECG) taken from the surface of the body and cardiac electrograms (EGM) taken from within the heart.

Rooted in deep data science and covered by more than 35 pending and registered patents, the NeuTrace EP Data Biome is a proprietary and device-agnostic platform for holistic in-procedure data integration and novel real-time AI applications. A portfolio of EP applications is under development with the potential to increase procedure accuracy, reduce procedure time, and improve patient safety and outcomes. Advanced deep learning techniques on in-procedure EGM and ECG data feeds, combined with pre- and post-procedure ECG and EMR data records, will enable new and improved ECG-AI based diagnostic and pre-diagnostic algorithms for early disease detection and treatment.

“Anumana is pioneering new ground in cardiology AI software solutions that span the entire patient journey,” said David McMullin, chief business officer of Anumana. “With its deep learning models detecting patterns too subtle for the human eye to see, from undiagnosed disease in routine ECGs to real-time EGM signals during critical EP procedures, Anumana is on a mission to improve patient care by unlocking the electrical language of the heart as never before.”

“We’ve been impressed by the complementary depth, breadth, and strength of the Anumana and nference teams and are excited by the transformative potential of the combined organizations,” said Srijoy Mahapatra, M.D., president and chief operating officer of NeuTrace. “Combining the power of NeuTrace’s EP Data Biome with EMR and other data modalities of nference’s nSights platform has the potential to unlock game-changing AI applications in early cardiovascular disease detection, rhythm management, and EP procedure safety, efficacy, and effectiveness, for improved long-term outcomes.”

"NeuTrace promises to significantly improve care through applied AI in both expert and non-expert EP labs,” said Pierre Jais, M.D., LYRC-Bordeaux and NeuTrace medical advisor. “As new tools come on-line in the EP lab, we will need artificial intelligence more than ever. By pairing these intraprocedural data with ECGs and full medical records, Anumana has the opportunity for AI-tailored recommendations patient-by-patient, which would be true precision medicine.”

"Electrophysiology and other cardiology procedures are extremely rich in data that has largely remained untapped when it comes to machine learning and deep learning techniques,” said K. Shivkumar, M.D., Ph.D., Director of UCLA Cardiac Arrhythmia Center & Interventional Cardiovascular Programs.* “The techniques and products that Anumana and nference are developing, especially when integrated with NeuTrace’s in-procedure technology, are groundbreaking not only in cardiology, but also when applied to other organs such as the brain and kidney. I look forward to the next-gen technologies that Anumana and nference’s combination with NeuTrace will produce.”

NeuTrace was founded by Dr. K.Shivkumar and his colleagues, and molded with the business vision and guidance from Raghu Mendu and NC Murthy, along with leading AI/ML and Data technology experts. NeuTrace’s mission is to democratize clinical practice, starting with cardiac electrophysiology, by applying its agnostic technology platform and AI in clinical procedures, to greatly improve the efficiency, effectiveness, and safety of patient care and outcomes.

Anumana, an AI-driven health technology company and portfolio company of nference and Mayo Clinic Platform, is harnessing industry-leading AI and translational science to unlock the electrical language of the heart as never before. Anumana algorithms have been developed, trained, and validated using clinical data from Mayo Clinic and other leading institutions to detect hidden diseases using ECG-AI and enhance and improve EP procedures through real-time AI techniques. Multiple Anumana algorithms have received FDA Breakthrough Device Designation and are currently undergoing rigorous clinical trial validation. Anumana software devices are designed for real-world physician use, integrating into existing workflows at the point-of-care, thereby reducing costs and enhancing quality of life. Anumana algorithms are investigational medical devices and have not yet received regulatory approval or clearance. For more information, visit anumana.ai and follow Anumana on LinkedIn and Twitter.

Through its powerful technology platform and software, nference is transforming health care by making biomedical knowledge computable. Its partnership with Mayo Clinic and other renowned academic medical centers has given nference an opportunity to synthesize decades of institutional knowledge, producing real-world evidence in real-time by converting large amounts of de-identified data into deep insights to advance discovery and development of diagnostics and therapeutics. Its proprietary AI-enabled software platform, nSights, has been used to accelerate life sciences research, development, and clinical care in significant ways, including biomarker discovery and validation, real-world evidence generation leveraging real-world data, early disease detection, public health policy generation and validation, and more. For more information, visit www.nference.com and follow nference on LinkedIn and Twitter.

*Dr. Shivkumar is a founder of NeuTrace, and the views expressed by him are his own and do not represent the views of UCLA.

Anumana acquires NeuTrace, a medical technology company advancing novel in-procedure AI applications for electrophysiology (EP) 

NS Medical Devices: Anumana said that the acquisition strengthens its position as a developer of AI medical software for cardiac EP, powered by nference’s nSights real-world evidence platform.

Anumana acquires AI medical software provider NeuTrace

Health IT Analytics: For years, data analytics in healthcare has been a frequent buzzword among industry leaders. The ability to leverage AI, machine learning, and other technologies to gain actionable insights from massive amounts of data is an exciting prospect, but one that has been notoriously difficult to realize. With the onset of the pandemic, healthcare was forced to come face-to-face with its many data challenges, from collection to accuracy and analysis. In response, the industry has ramped up its efforts to improve data analytics capabilities – with tech companies playing a major role. 

Tech Companies Aim to Expand Use of Data Analytics in Healthcare

The Tech Tribune: An exclusive Tech Tribune Q&A with Venky Soundararajan (co-founder and CSO) of nference, which was honored in our: 2022, 2021, 2020 Best Tech Startups in Cambridge. 

FIERCE Healthcare: Mayo Clinic has launched a new initiative to collect and analyze patient data from remote monitoring devices and diagnostic tools and to use artificial intelligence to accelerate diagnoses and disease prediction. To support this effort, the hospital is launching two new companies, Anumana and Lucem Health, which are working with AI and medical algorithms that tap into the hospital's patient data.

Mayo Clinic launches 2 new companies to use patient data and AI to advance early disease detection

Biz Journals: If 2020 was a strange year for Boston's startups, companies and nonprofits, 2021 was its equally weird sequel. But the continuing pandemic, global supply-chain shortages, economic turmoil and a remote work revolution haven't stopped them from innovating.

BOSTINNO'S 2021 INNO ON FIRE: Meet the 50 startups and individuals setting Boston's innovation ecosystem ablaze.

Health Day: An artificial intelligence (AI) algorithm that uses data from electrocardiography can help increase the diagnosis of low ejection fraction (EF), according to a study published online May 6 in Nature Medicine.

AI Algorithm Aids Early Detection of Low Ejection Fraction

Developed in collaboration with Mayo Clinic, with support from Pfizer, this ECG-AI algorithm aims to aid physicians in earlier identification of cardiac amyloidosis

CAMBRIDGE, Mass., June 21, 2023 – Anumana, Inc., a leading AI-driven health technology company, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its ECG-AI algorithm designed to aid the early identification of cardiac amyloidosis, a life-threatening, rare, underdiagnosed cause of heart failure. This breakthrough device designation was granted to provide patients and healthcare providers timely access to the algorithm, subject to approval. 

Anumana previously announced a multi-year research agreement with Pfizer to develop ECG-AI solutions to aid in early identification of cardiac amyloidosis. The Breakthrough Device Designation recognizes the significant potential of this algorithm, and the designation is a key regulatory milestone under the agreement, providing an expedited pathway for regulatory review.1 Anumana plans to conduct a retrospective clinical validation trial and pursue De Novo classification for the algorithm as Software as a Medical Device (SaMD) and aims to gain regulatory approval for the algorithm for the detection of cardiac amyloidosis in the U.S., Europe, and Japan. 

Cardiac amyloidosis is an underdiagnosed disease that often leads to heart failure.2 Early diagnosis is crucial to enable timely interventions that can improve outcomes.3 However, diagnosing this condition early can be challenging because of the rarity of the disease, which often presents with nonspecific signs and symptoms.4  While a standard ECG is obtained during the evaluation of these nonspecific symptoms, human interpretation of the ECG often misses subtle combinations of features that may indicate cardiac amyloidosis.5,6

Developed in collaboration with Mayo Clinic, Anumana’s ECG-AI algorithm aims to address this medical need with breakthrough technology that facilitates earlier identification of this underdiagnosed condition. Anumana is currently developing this algorithm as a SaMD, with the goal of integrating this solution into existing clinical workflows. 

“The use of AI algorithms to identify subtle signals in ECGs that are imperceptible to humans stands to transform cardiovascular medicine by allowing us to detect disease early, in more easily treated stages, potentially avoiding serious consequences,” said Paul Friedman, M.D., Chair of the Department of Cardiovascular Medicine at Mayo Clinic in Rochester and Chair of Anumana’s Mayo Clinic Board of Advisors. “It is encouraging to see an algorithm that can aid in identification of cardiac amyloidosis receive Breakthrough Device Designation, as it recognizes the importance of having new tools to detect rare cardiac diseases in ways never before possible.”

Anumana, a portfolio company of nference was founded in 2021 in collaboration with the Mayo Clinic Platform and has since developed a robust pipeline of FDA-ready ECG-AI algorithms. These algorithms have been validated in over 75 peer-reviewed publications - including two novel, real-world prospective studies published in Nature Medicine and The Lancet. Anumana has received four Breakthrough Device Designations from the U.S. FDA for algorithms aimed at early identification of low ejection fraction, pulmonary hypertension, hyperkalemia, and now, cardiac amyloidosis. 

“The ubiquitous nature of the painless, non-invasive Electrophysiology tests gives ECG-AI algorithms the potential to reach a larger number of patients earlier, something clinicians have long hoped for,” said Venky Soundararajan, PhD, Co-founder, and Chief Scientific Officer of Anumana and nference. “Receiving the FDA Breakthrough Device Designation for our Cardiac Amyloidosis ECG-AI Algorithm recognizes the significant potential of this tool to detect disease early.” 

Anumana, a leading AI-driven health technology company, and portfolio company of nference, is leveraging cutting-edge AI and industry-leading translational science to unlock the electrical language of the heart as never before. Anumana’s algorithms have been developed and trained on the nference nSights platform and validated in retrospective and prospective studies across various institutions both nationally and internationally. Anumana’s solutions aim to detect hidden diseases using ECG-AI algorithms and to enhance and improve interventional procedures through real-time AI insights. Currently, four Anumana algorithms have received FDA Breakthrough Device Designation and are currently undergoing rigorous clinical validation. Anumana has also received approval for two CPT® III Codes from the American Medical Association, establishing ECG-AI as a new innovative procedure. Anumana software devices are designed for real-world physician use, integrating into existing workflows at the point of care to reduce costs and enhance quality of life. Anumana was named one of Fierce Medtech’s Fierce 15 companies for 2022. For more information, visit anumana.ai and follow Anumana on LinkedIn and Twitter. 

Sam Choinski
Pazanga Health Communications for Anumana
schoinski@pazangahealth.com
(860) 301-5058

Anumana Receives U.S. FDA Breakthrough Device Designation for its Cardiac Amyloidosis Algorithm

Fierce Medtech: Since its humble beginnings back in 2012, the Fierce 15 has made a point of spotlighting the most exciting startups in medtech—those not only challenging the limits of both the tech and healthcare industries but also making real progress toward their lofty goals. The companies on this year’s list—which kicks off the second decade of Fierce Medtech’s Fierce 15—are setting the bar even higher. Anumana, a joint venture between Nference and the Mayo Clinic, is using artificial intelligence to dig into the peaks and valleys of standard electrocardiograms to pull out not-so-standard analyses.

Wall Street Journal: At Mayo cardiology, an AI tool has helped doctors diagnose new cases of heart failure and cases of irregular heart rhythms, which are called atrial fibrillation, potentially years before they might otherwise have been detected, said Dr. Paul Friedman, chair of the clinic’s cardiology department in Rochester, Minn.

How Doctors Use AI to Help Diagnose Patients

AI-driven startup from nference and Mayo Clinic Platform positioned to transform cardiac care

CAMBRIDGE, Mass., March 20, 2023 – Anumana, an AI-driven health technology company and portfolio company of nference, has been named one of Fierce Medtech’s 2022 Fierce 15. This prestigious honor indicates that the two-year-old company is well-positioned to transform cardiac care by leveraging cutting-edge AI and industry-leading translational science to unlock the electrical language of the heart.

“We are honored to be recognized as one of the Medtech Fierce 15 companies for 2022,” said David McMullin, Chief Business Officer of Anumana. “Anumana’s goal is to decode electrical signals from the heart as never before, empowering healthcare providers to improve patient care throughout the cardiac clinical pathway. We are excited to continue developing innovative solutions to the most pressing challenges facing cardiovascular disease diagnosis, treatment, and management.” 

Powered by nference’s nSights data platform, Anumana leverages ECG waveforms from the heart with deep, longitudinal electronic medical records (EMR) data at the patient level, developing state-of-the-art algorithms aimed to help physicians diagnose and treat cardiac disease earlier and more efficiently. Nference, which partners with leading healthcare systems such as Mayo Clinic and Duke Health, makes real-world data available includes multiple data modalities (clinical, molecular, and imaging). 

Anumana’s algorithms for early detection of low ejection fraction, pulmonary hypertension, and hyperkalemia, have received Breakthrough Device Designation from the U.S. FDA. Its robust pipeline of FDA-ready algorithms has been validated with significant prospective clinical evidence in over 75 peer-reviewed publications - including two first-of-their-kind studies published in Nature Medicine and The Lancet. Anumana develops these algorithms in collaboration with the Mayo Clinic Platform and has received sponsorship from strategic pharmaceutical leaders such as Janssen,  Novartis, and Pfizer to further develop and commercialize ECG-AI algorithms.

Anumana’s AI platform utilizes widely accessible screening tools and is built to seamlessly integrate into existing clinical workflows, providing clinicians with real-time insights, accelerating the time to guideline-directed medical therapy, reducing costs, and improving patient outcomes. Anumana seeks regulatory clearances for the platform as software as a medical device (SaMD) and has early milestones for reimbursement in place with two Category III CPT® codes that became effective January 1st, 2023. 

Fierce Medtech’s Fierce 15, launched in 2012, is an annual special report that spotlights the most exciting startups in medtech. This year’s report features the 15 medtech startups that made the biggest splashes in 2022 and aimed to pick the players they think are “the most capable of delivering on their promises to advance the art and science of healthcare.”

Anumana, an AI-driven health technology company and portfolio company of nference, is leveraging cutting-edge AI and industry-leading translational science to unlock the electrical language of the heart as never before. Anumana algorithms have been developed, trained, and validated using clinical data from Mayo Clinic and other leading institutions to detect hidden diseases using AI-ECG algorithms and to enhance and improve interventional procedures through real-time AI insights. Multiple Anumana algorithms have received FDA Breakthrough Device Designation and are currently undergoing rigorous clinical validation. Anumana software devices are designed for real-world physician use, integrating into existing workflows at the point of care to reduce costs and enhance quality of life. Anumana algorithms are investigational medical devices and have not yet received regulatory approval or clearance. For more information, visit anumana.ai and follow Anumana on LinkedIn and Twitter.

Pazanga Health Communications for Anumana

Anumana Named to Fierce Medtech’s 2022 Fierce 15

Based on pioneering research from Mayo Clinic, ECG-AI LEF aims to aid physicians in identifying low ejection fraction in patients at risk of heart failure

CAMBRIDGE, Mass. – Oct. 2, 2023 – Anumana, Inc., a leading AI-driven health technology and nference portfolio company working in collaboration with Mayo Clinic, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance for ECG-AI LEF, a breakthrough artificial intelligence (AI)-powered medical device to detect low ejection fraction (LEF) in patients at risk of heart failure.

LEF, or a weak heart pump, is a significant, at times asymptomatic, and commonly undiagnosed indicator of heart failure.1 The increasing prevalence of heart failure and its associated morbidity, mortality, rehospitalizations, and societal costs2,3 underscores the need to identify and manage patients with LEF.

“Anumana’s ECG-AI LEF fills an important unmet need – the lack of an easily accessible point-of-care, noninvasive, and inexpensive tool to screen for a weak heart pump,” said Paul Friedman, M.D., chair of the Department of Cardiovascular Medicine at Mayo Clinic in Rochester, Minn. and chair of Anumana’s Board of Advisors. “It allows identification of otherwise hidden disease, for which many effective, lifesaving treatments are available – once the presence of the disease is known.”

Developed in partnership with Mayo Clinic, Anumana’s ECG-AI LEF is an innovative software-as-a-medical device (SaMD) designed to screen for LEF in adults at risk for heart failure using data from a routine 12-lead electrocardiogram (ECG), a rapid and common test used in both primary and specialty care. Based on pioneering research from Mayo Clinic,4 the algorithm has been developed utilizing over 100,000 ECG and echocardiogram data pairs from unique patients and has been clinically tested in more than 25 studies involving more than 40,000 patients in the U.S. and internationally.5

Anumana’s ECG-AI LEF was clinically validated in a multi-site, retrospective clinical study of 16,000 racially diverse patients, achieving its primary endpoint with an 84.5% sensitivity and 83.6% specificity.6 ECG-AI LEF achieved an AUROC7 of 0.932, demonstrating an ability to differentiate between LEF and ejection fraction (EF) >40% extremely well (a score ≥0.90 is considered excellent8) and better than most tests currently used in heart failure standard of care.9

Additionally, the EAGLE study, a groundbreaking prospective, randomized, controlled clinical trial by Mayo Clinic evaluated the use of an investigational version of the algorithm in routine clinical care of 22,641 adults by 120 primary care teams from 45 clinics or hospitals, demonstrating that ECG-AI LEF implementation improved clinician’s ability to diagnosis of LEF by 31% versus standard of care without increasing the overall rate of echocardiogram usage.10

ECG-AI LEF is one of Anumana’s broad pipeline of algorithms, including three additional FDA breakthrough device designation algorithms (pulmonary hypertension, cardiac amyloidosis, and hyperkalemia), and is founded on more than six years of pioneering ECG-AI research and development at Mayo Clinic, including nearly 100 peer-reviewed publications to date.

“Anumana was established in 2021 by nference in partnership with Mayo Clinic to unlock the electrical language of the heart through deep learning and improve disease diagnosis and patient care,” said Murali Aravamudan, co-founder and CEO of Anumana and nference. “In the short time of two years we have secured multiple FDA breakthrough device designations, entered multi-year agreements with three pharma partners, successfully established two new medical procedure codes for ECG AI technology, and now achieved our first FDA breakthrough medical device clearance. This is a significant milestone, and we are excited about the next phase of the journey, deploying our technology in the U.S. and globally to empower clinicians and enhance real-world clinical care.”

Anumana is focused on driving fast-paced adoption of the new ECG-AI category, clinically developing and commercializing its novel technologies in healthcare. The newly FDA-cleared ECG-AI LEF can be easily integrated with various ECG information management systems or directly with a patient’s electronic health record via Anumana’s web-based ECG Viewer to support clinical decision-making.

Anumana spearheaded the effort to bring reimbursement to ECG-AI, receiving approval for two Category III CPT® codes from the American Medical Association in 2022. These codes are now available and designed to facilitate the use, adoption, and potential reimbursement of emerging technologies in clinical workflows.

To learn more about ECG-AI LEF and schedule a demo, visit us at ECG-AI LEF.

Anumana is a leading AI-driven health technology company leveraging cutting-edge AI and industry-leading translational science to unlock the electrical language of the heart as never before. The company was founded by nference in partnership with Mayo Clinic to leverage the clinical and technical expertise of both organizations to develop innovative ECG-AI technology from an investigational resource to a clinically meaningful tool for clinicians to advance patient care. Anumana’s software-as-a-medical device (SaMD) solutions aim to detect hidden diseases using ECG-AI algorithms to enhance and improve interventional procedures through real-time AI insights.

Anumana was named one of Fierce MedTech’s Fierce 15 companies for 2022. Follow Anumana at anumana.ai and on LinkedIn and Twitter.

Dr. Friedman and Mayo Clinic have a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education, and research.

1.     Jaskanwal D Sara, Takumi Toya, Riad Taher, Amir Lerman, Bernard J Gersh, Nandan S Anavekar. Asymptomatic Left Ventricle Systolic Dysfunction. European Cardiology Review 2020, 15:e13; https://doi.org/10.15420/ecr.2019.14.

2.     Tsao, C.W., Aday, A.W., Almarzooq Z.I., et al. Heart Disease and Stroke Statistics—2023 Update: A Report From the American Heart Association. Circulation Vol. 147, No. 8; https://www.ahajournals.org/doi/10.1161/CIR.0000000000001123#d330256e1.

3.     Khazanie P, Allen LA. Systematizing Heart Failure Population Health. Heart Fail Clin. 2020 Oct;16(4):457-466. Doi: 10.1016/j.hfc.2020.06.006. Epub 2020 Jul 21. PMID: 32888640; PMCID: PMC7737815; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7737815/.

4.     Attia, Z.I., Kapa, S., Lopez-Jimenez, F. et al. Screening for cardiac contractile dysfunction using an artificial intelligence–enabled electrocardiogram. Nat Med 25, 70–74 (2019); https://doi.org/10.1038/s41591-018-0240-2.

5.     Anumana data on file and published studies.

6.     Anumana data on file (NCT04963218).

7.     Area Under the Receiving Operating Characteristic curve (AUROC) is a performance metric commonly used to evaluate the ability of a model to distinguish between two classes. An AUROC of 0.5 suggests that the model is no better than random and an AUROC of 1.0 indicates a perfect classifier; https://en.wikipedia.org/wiki/Receiver_operating_characteristic.

8.     Muller MP, Tomlinson G, Marrie TJ, Tang P, McGeer A, Low DE, et al. Can routine laboratory tests discriminate between severe acute respiratory syndrome and other causes of community-acquired pneumonia? Clin Infect Dis. 40:1079–86 (2005); https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8831439/.

9.     Such as NT-proBNP, a common blood test used to help identify LEF today with an AUROC of 0.83; Koschack, J., Scherer, M., Lüers, C. et al. Natriuretic peptide vs. clinical information for diagnosis of left ventricular systolic dysfunction in primary care. BMC Fam Pract 9, 14 (2008); https://doi.org/10.1186/1471-2296-9-14h.

10.   Yao, X., Rushlow, D.R., Inselman, J.W. et al. Artificial intelligence–enabled electrocardiograms for identification of patients with low ejection fraction: a pragmatic, randomized clinical trial. Nat Med 27, 815–819 (2021); https://doi.org/10.1038/s41591-021-01335-4.

Anumana Receives U.S. FDA 510(k) Clearance for ECG-AI Algorithm to Detect Low Ejection Fraction

CAMBRIDGE, Mass. – October 19, 2023 – Anumana, Inc., a leading AI-driven health technology company and portfolio company of nference, today announced that Maulik Nanavaty has joined Anumana as chief executive officer and member of the Board of Directors. Murali Aravamudan, co-founder of Anumana and nference, has transitioned to executive chairman of the Anumana Board of Directors while continuing as CEO of nference. Nanavaty will lead Anumana through a period of growth as the company begins deploying and commercializing its multi-indication ECG-AI platform technology.

Nanavaty joins Anumana after 18 years at Boston Scientific, where he served as a senior executive with extensive commercial and operational medical device experience in U.S. and international markets. Most recently, Nanavaty was senior vice president and president of Neuromodulation at Boston Scientific, leading the development and commercialization of microelectronic implantable technologies and software used to treat neurological diseases and other chronic conditions. Prior to this role, he served as president of Boston Scientific Japan, and previously vice president and general manager of Interventional Cardiology, Boston Scientific Japan. Prior to Boston Scientific, Nanavaty spent 16 years in various executive positions at Baxter International. 

“It is a delight to announce and welcome Maulik as the new CEO of Anumana on the heels of the recent FDA clearance of our breakthrough ECG-AI LEF device,” said Aravamudan. “Maulik’s decades of experience developing and bringing to market innovative medical products globally is exactly what is needed to build Anumana into a best-in-class multimodal cardiovascular AI enterprise. I am confident his leadership will play a pivotal role in guiding Anumana through its next phase of growth.”

Anumana’s ECG-AI platform represents a breakthrough approach to ECG interpretation, enabling identification of hidden cardiovascular diseases from standard ECGs at the point of care, for which effective, lifesaving treatments may be available. The company’s lead algorithm, ECG-AI LEF, recently received FDA clearance for detecting low ejection fraction, a common undiagnosed indicator of heart failure,1 a prevalent progressive disease that affects over 6 million people in the U.S. and is associated with a significant total annual healthcare cost.2 In addition to the breakthrough ECG-AI LEF, Anumana’s expansive development pipeline includes three additional algorithms with FDA breakthrough designation. The company has multiple ongoing partnerships with leading pharmaceutical companies to further develop and commercialize algorithms in the pipeline.

“Anumana’s mission to unlock the electrical language of the heart in order to improve patient care is incredibly inspiring, and I am grateful for the opportunity to lead its continued progress,” said Nanavaty. “The company has accomplished fast-paced disruptive innovation within just two years since its founding, in close partnership with Mayo Clinic's world-renowned cardiologists and business collaborators. Together, we will build on and accelerate this evidence-based innovative platform, bringing our unique AI-based portfolio of cardiac disease related products to market globally, with real-world evidence in transforming patient outcomes.”

In addition to his role as CEO of Anumana, Nanavaty joins nference as president, Ventures. He will continue to serve as a board member of Rani Therapeutics, a publicly listed biotherapeutics company. Nanavaty earned a Ph.D. in Pharmaceutical Sciences from the University of Illinois and an M.B.A. from the University of Chicago.

Anumana is a leading AI-driven health technology company leveraging cutting-edge AI and industry-leading translational science to unlock the electrical language of the heart as never done before. The company was founded by nference and Mayo Clinic to leverage the clinical and technical expertise of both organizations to develop innovative AI technology applied to ECG, electrophysiology, and hemodynamics, from an investigational resource to a clinically meaningful tool for clinicians to advance patient care. Anumana’s software-as-a-medical device (SaMD) solutions aim to detect hidden diseases using ECG-AI algorithms to enhance and improve care through real-time AI insights. Anumana SaMDs are designed for real-world physician use, integrating into existing workflows at the point of care to reduce costs and enhance quality of life. Anumana utilizes the nference nSights platform to design, develop, and train new algorithms, and its pipeline of algorithms have been evaluated in retrospective and prospective studies across various institutions both nationally and internationally, including nearly 100 peer-reviewed publications to date. In addition to the company’s first FDA-cleared algorithm, ECG-AI LEF, to detect low left ventricular ejection fraction, three Anumana algorithms (cardiac amyloidosis, pulmonary hypertension, and hyperkalemia) have received FDA Breakthrough Device Designation and are currently undergoing rigorous clinical validation to support additional regulatory submissions.  

Anumana was named one of Fierce MedTech’s Fierce 15 companies for 2022. For more information, visit anumana.ai and follow Anumana on LinkedIn and X (formerly Twitter). 

Through its powerful technology platform and software, nference is transforming healthcare by making biomedical knowledge computable. Its partnerships with major academic medical centers empower nference to synthesize decades of institutional knowledge, producing real-world evidence (RWE) in real time by converting large amounts of de-identified data into deep insights to advance discovery and development of diagnostics and therapeutics. Its proprietary AI-enabled software platform, nSights, harnesses the power of federated learning to accelerate life sciences research, development, and clinical care in significant ways, including biomarker discovery and validation, RWE generation leveraging real-world data, early disease detection, public health policy generation and validation, and more. nference is headquartered in Cambridge, Mass. Follow nference on LinkedIn and Twitter. Visit us at www.nference.com.

1.         Jaskanwal D Sara, Takumi Toya, Riad Taher, Amir Lerman, Bernard J Gersh, Nandan S Anavekar. Asymptomatic Left Ventricle Systolic Dysfunction. European Cardiology Review 2020, 15:e13; https://doi.org/10.15420/ecr.2019.14.

2.         Khazanie P, Allen LA. Systematizing Heart Failure Population Health. Heart Fail Clin. 2020 Oct;16(4):457-466. doi: 10.1016/j.hfc.2020.06.006. Epub 2020 Jul 21. PMID: 32888640; PMCID: PMC7737815; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7737815/.

Fierce Biotech: Two years after its launch as a joint venture between the Mayo Clinic and Nference to develop artificial intelligence algorithms capable of pulling out new insights from routine electrocardiogram results, Anumana has earned its first 510(k) clearance from the FDA for one of those tools.

Anumana earns first full FDA clearance for AI to detect low ejection fraction

Cardiovascular Business: Anumana, a Massachusetts-based healthcare technology company focused on artificial intelligence (AI), has received a breakthrough device designation from the U.S. Food and Drug Administration (FDA) for a new algorithm designed to identify signs of cardiac amyloidosis in electrocardiograms (ECGs).

FDA grants breakthrough designation for new AI model to detect cardiac amyloidosis in ECG results

Medical Device Network: The US Food and Drug Administration (FDA) has granted breakthrough device designation (BDD) for the electrocardiogram-artificial intelligence (ECG-AI) algorithm by AI-driven health technology company Anumana. The algorithm is intended for the early detection of cardiac amyloidosis, an underdiagnosed cause of heart failure. Anumana has worked with the Mayo Clinic to develop the ECG-AI algorithm. The company previously signed a multi-year research agreement with Pfizer for the development of ECG-AI solutions to facilitate cardiac amyloidosis early identification.

FDA grants breakthrough designation for Anumana’s ECG-AI algorithm

Mass Device: Anumana announced that it received FDA 510(k) clearance for its AI-powered ECG-AI LEF medical device.

Anumana wins FDA clearance for ECG-AI algorithm

DAIC: Anumana, Inc., a leading AI-driven health technology company, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its ECG-AI algorithm designed to aid the early identification of cardiac amyloidosis, a life-threatening, rare, underdiagnosed cause of heart failure. This breakthrough device designation was granted to provide patients and healthcare providers timely access to the algorithm, subject to approval.

Healio: Anumana announced it received FDA breakthrough device designation for its artificial intelligence-guided ECG algorithm for the early identification of cardiac amyloidosis.

AI algorithm for detection of cardiac amyloidosis gains FDA breakthrough device status

Healio: An AI-powered device to identify low left ventricular ejection fraction in patients at risk for HF gained 510(k) clearance from the FDA.

AI-powered device to identify low LV ejection fraction gains FDA 510(k) clearance

Fierce Biotech: For the fourth time in half as many years, Anumana has earned the FDA’s breakthrough device designation for another of its artificial intelligence algorithms designed to catch hard-to-spot heart conditions in their earliest stages.

Anumana's Pfizer-backed cardiac amyloidosis-spotting AI algorithm nabs FDA breakthrough tag

Novartis Pharmaceuticals Corporation to collaborate on development of new medical device software for earlier detection and intervention in cardiovascular disease

CAMBRIDGE, Mass., July 13, 2022 – Anumana, Inc., an AI-driven health technology company and portfolio company of nference, has launched a multi-year strategic collaboration with Novartis Pharmaceuticals Corporation (“Novartis”) to deploy a series of artificial intelligence (AI)-powered software solutions that will detect hidden cardiovascular conditions. The collaboration will drive development and delivery of electrocardiogram (ECG) AI algorithms to help physicians accelerate detection and intervention for patients with previously undetected life-threatening heart disease. The ECG AI algorithm is still in development and not yet FDA authorized for commercial clinical use.

The collaboration will support Anumana’s efforts to implement AI-enabled diagnostic software that can detect signals from ECGs that humans cannot interpret. The collaboration will initially focus on cardiovascular diseases. Working with its expert partners from Mayo Clinic, Anumana will deploy novel solutions that use AI to analyze an ECG, a widely available, painless test that records the heart’s electrical signals to identify undiagnosed left ventricular dysfunction, or a weak heart pump, which can lead to heart failure. The AI will also screen for atherosclerotic cardiovascular disease, which can lead to heart attack and stroke. In addition, an evidence-based, digital point-of-care solution will be developed to guide in optimizing guideline-directed medical therapies with the aim to lower risk for potentially avoidable hospitalizations and cardiovascular death. 

“Anumana technology is designed to help physicians identify patients who are at maximum risk of heart failure, long before they develop symptoms,” said Murali Aravamudan, CEO of Anumana. “Bringing together premier global organizations will allow us to expand access to best-in-class, AI-powered digital tools to benefit patients through earlier detection and intervention, when and where health care providers need it most.”

“Many heart diseases develop for years before signs and symptoms appear, but the first event may be life threatening,” said Paul Friedman, M.D., Chair of the Department of Cardiovascular Medicine at Mayo Clinic and Chair of Anumana’s Mayo Clinic Board of Advisors. “AI enables us to uncover hidden signals our bodies transmit to detect otherwise occult heart diseases, potentially years before symptoms appear. This collaboration has the potential to transform the use of an ubiquitous inexpensive test, the ECG, with the aim of democratizing disease detection and helping medical care teams to proactively manage heart disease ahead of time and prevent some clinical events from ever happening.”

“Cardiovascular disease is a widespread and multifactorial disease and, in order to mitigate its impact, we must look beyond therapeutic innovation and reimagine how we approach cardiovascular care,” said Victor Bulto, President, Novartis Innovative Medicines US. "Novartis is proud to collaborate with Anumana on innovative and data-driven solutions to better predict the risk of life-threatening heart disease, further driving forward our commitment to improving patient experiences and population health outcomes in this patient population.”  

The Mayo Clinic Cardiology team, led by Dr. Friedman, pioneered the application of AI in cardiology and developed several algorithms based on millions of ECGs, including a low ejection fraction algorithm that received FDA Breakthrough Device Designation in 2019 and Emergency Use Authorization for COVID-19 in 2020. Further validating the technology, a recent study presented by Mayo Clinic used a modified version of Anumana’s 12-lead ECG algorithm to detect left ventricular dysfunction with single-lead ECGs in smartwatches. These algorithms are licensed to Anumana for development of clinical solutions and have been validated by over 30 peer-reviewed publications, including a first of its kind prospective clinical impact study on low ventricular ejection fraction that was published in Nature Medicine in 2021. These software solutions are currently in development with each algorithm as a candidate for marketing authorization through an FDA DeNovo request.

About Anumana
Anumana, an AI-driven health technology company and a portfolio company of nference and Mayo Clinic Platform, is harnessing industry-leading AI and translational science to decode the electrocardiogram as never before – as a deep predictive tool and biomarker of disease – empowering care providers to help patients early. Anumana algorithms have been developed, trained, and validated using clinical data from Mayo Clinic and are undergoing rigorous clinical trial validation. Anumana is developing AI-enabled ECG algorithms for real-world physician use, integrating point-of-care applications into existing workflows, thereby reducing costs and enhancing quality of life. Anumana’s AI-enabled tools can diagnose hidden conditions earlier than ever before. Anumana’s algorithms are investigational medical devices and have not yet received regulatory approval or clearance. For more information, visit anumana.ai and follow Anumana on LinkedIn & Twitter.

Anumana 
Andrea Sampson, Sampson Public Relations Group
asampson@sampsonprgroup.com
562.304.0301

Anumana Collaborates with Leading Global Health Care Company to Detect Heart Disease Using Artificial Intelligence

DAIC: Anumana, Inc., an AI-driven health technology company from nference, Inc., today announced that the U.S. Food & Drug Administration (FDA) has granted Breakthrough Device Designation to itsAI-enhanced, ECG-basedPulmonary Hypertension(PH) Early Detection Algorithm. The algorithm is a precise, non-invasive screening tool that addresses an unmet need for earlier diagnosis of patients with pulmonary hypertension, which may otherwise go unnoticed until the disease has advanced, delaying treatment initiation, thereby limiting treatment efficacy and adversely impacting patient outcomes.

HC Innovation Group: Mayo Clinic announced a new technology platform initiative designed to deliver clinical decision support tools, diagnostic insights and care recommendations to help clinicians make faster and more accurate diagnoses and provide continuous care to patients.

Anumana in the News

J&J Hired Thousands of Data Scientists. Will The Strategy Pay Off?

Anumana Appoints Maulik Nanavaty as CEO

Anumana earns first full FDA clearance for AI to detect low ejection fraction

Anumana wins FDA clearance for ECG-AI algorithm

AI-powered device to identify low LV ejection fraction gains FDA 510(k) clearance

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