Anumana and InfoBionic.Ai Collaboration for Remote Cardiac Monitoring Tech

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CAMBRIDGE, Mass, June 27, 2024 Anumana, a leading AI-driven health technology company and portfolio company of nference, announced a new study that revealed promising results in support of further development of its investigational pulmonary hypertension (PH) algorithm. The study, “An electrocardiogram-based AI algorithm for early detection of pulmonary hypertension,” which was published in the European Respiratory Journal, determined that the algorithm used in the study can detect PH using routine 12-lead electrocardiogram (ECG) data.

PH is a severe, progressive disease where delayed diagnosis is associated with a higher risk of morbidity and mortality.1-5 Despite an increasing number of available treatments for the disease, diagnostic delays – often of more than two years from symptom onset - are common, due to the non-specific symptoms at presentation.6-9  To address this challenge, Anumana, in collaboration with Mayo Clinic, Vanderbilt University Medical Center (VUMC), and Janssen Research & Development, LLC, a Johnson & Johnson company, has developed an Al algorithm designed to detect PH using routinely collected 12-lead ECG data. 

In the newly published study, a convolutional neural network developed for detecting PH was trained and validated using retrospective ECG and either right heart catheterization or echocardiogram data from 39,823 PH-likely patients and 219,404 control patients from Mayo Clinic. The algorithm used in the study was further validated on an additional 6,045 PH-likely patients and 24,256 control patients from VUMC. The algorithm demonstrated promising performance in identifying PH, achieving an area under the receiver operating characteristic curve (AUC) of 0.92 in the diagnostic test set at Mayo Clinic and 0.88 at VUMC, where AUC values range from 0 to 1.10


The PH algorithm received Breakthrough Device designation from the FDA in 2022, and Anumana is continuing to develop the PH algorithm in pursuit of FDA clearance and CE marking. Anumana has previously received FDA 510(k) clearance for its ECG-AI™ LEF algorithm, which helps clinicians detect low ejection fraction in patients at risk of heart failure.

“The promising data from our study suggest that an AI algorithm has the potential to non-invasively detect PH at an early stage using standard ECGs. This finding marks a significant step forward in the care and management of PH patients who often have a long diagnostic journey,” said Dr. Hilary DuBrock, a Mayo Clinic pulmonologist and lead author of the study. 

“These new data underscore the potential of AI algorithms to empower clinicians to uncover diseases earlier, improve patient outcomes and bring us one step closer to our mission to transform cardiac care,” said Maulik Nanavaty, CEO of Anumana. “We’re continuing to work closely with our partners to further clinically validate this much-needed algorithm, which can help clinicians worldwide get PH patients into treatment sooner to address symptoms and prolong life.” 

Mayo Clinic has 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.


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 collaboration with Mayo Clinic to leverage the clinical and technical expertise of both organizations to develop innovative ECG-AI technology into a clinically meaningful, medical-grade, and easy to use tool for clinicians to advance patient care. Anumana’s software-as-a-medical device (SaMD) ECG-AI™ solutions aim to detect diseases earlier using standard-of-care ECG readings, enabling clinicians to enhance and improve care with real-time AI insights.   

Anumana’s lead algorithm, ECG-AI™ LEF is now available in the U.S. To learn more about how the algorithm can help clinicians identify low ejection fraction earlier and schedule a demo, visit us at ECG-AI LEF.  

schoinski@pazangahealth.com                                    

(860) 301-5058                              


McLaughlin VV et al. .J Am Coll Cardiol 2018; 71(7):7522–763.​

Gall H et al. J Heart Lung Transplant 2017; 36(9):9572–967. ​

Frost AE et al. Chest 2013; 144(5):1521–1529. ​

Nickel H et al. Eur Respir J 2012; 39(3):589–596. ​

Vachiéry JL et al. Eur Respir Rev 2012; 21(123):40–47.

Brown LM, Chen H, Halpern S, et al. Delay in recognition of pulmonary arterial hypertension: factors identified from the REVEAL Registry. Chest 2011: 140(1): 19-26.

Didden EM, Lee E, Wyckmans J, et al. Time to diagnosis of pulmonary hypertension and diagnostic burden: A retrospective analysis of nationwide US healthcare data. Pulm Circ 2023: 13(1): e12188.

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(1): 67.

Maron BA, Humbert M. Finding pulmonary arterial hypertension-switching to offense to mitigate disease burden. JAMA cardiology 2022: 7(4): 369-370.

Hajian-Tilaki, K. Caspian J Intern Med. 2013 Spring; 4(2): 627-635.

Data from Anumana’s New Study Show AI Algorithm Has the Potential to Detect Pulmonary Hypertension Early Using ECG Data

CAMBRIDGE, Mass. – June 25, 2024 – Anumana, a leading AI-driven health technology company and portfolio company of nference, and InfoBionic.Ai, a digital health company specializing in remote cardiac monitoring and diagnostic solutions, today announced a joint research collaboration agreement to develop and commercialize the next generation of remote cardiac care solutions, combining Anumana’s breakthrough ECG-AI™ technology and InfoBionic.Ai’s MoMe ARC® platform. 

By leveraging Anumana's ECG-AI algorithms, developed and validated in collaboration with Mayo Clinic, this initiative aims to enhance InfoBionic.Ai’s MoMe ARC Platform’s ability to detect and intervene in cardiac diseases earlier in the remote patient monitoring setting, with the potential to improve patient outcomes. Anumana and InfoBionic.Ai, both Mayo Clinic portfolio companies,1,2 will continue to work closely with Mayo Clinic under this research agreement.

“It is exciting to see the convergence of our pioneering work in artificial intelligence and remote patient monitoring through this new partnership between Anumana and InfoBionic.Ai,” said Peter Noseworthy, MD, chair of the Heart Rhythm Services Division of Cardiovascular Medicine at Mayo and a board director at InfoBionic.Ai. “By combining InfoBionic.Ai’s remote monitoring solutions with Anumana’s innovative ECG-AI algorithms, including the FDA-cleared algorithm for detecting low ejection fraction (LEF), we aim to equip healthcare providers with the latest cutting-edge tools to detect underlying cardiac conditions earlier, enabling timely intervention and personalized care. It’s a thrilling time for cardiology."

“This collaboration marks an important step in Anumana’s mission to revolutionize cardiac care by enhancing the power of ECG with AI,” said Maulik Nanavaty, CEO of Anumana. “Since the founding of Anumana, our vision has been to elevate the utility of ECG with AI across all the settings in which ECGs are used. By joining forces with InfoBionic.Ai, we are expanding our capabilities from 12 leads in clinical settings to wearable lower-lead ECGs in patients’ homes. We look forward to bringing our AI technology to meet patients and physicians where they are, ultimately benefiting both worldwide.” 

Under the agreement, InfoBionic.Ai and Anumana will develop and integrate Anumana's ECG-AI algorithms, starting with the FDA cleared ECG-AI LEF algorithm, into InfoBionic.Ai's continuous and remote cardiac monitoring platform, allowing the ability to detect LEF and other conditions through the remote monitoring of cardiac activity. The companies will also work together to validate the clinical utility of the integrated solution and seek regulatory clearance to bring this technology to market.

Anumana has received FDA Breakthrough Device Designation for four of its algorithms: low ejection fraction, pulmonary hypertension, cardiac amyloidosis, and hyperkalemia. Its ECG-AI platform won the 2024 MedTech Breakthrough Award for “Best New Technology Solution- Cardiology.” ECG-AI LEF, the company’s FDA-cleared AI algorithm using routine 12-lead ECG data to detect low ejection fraction (LEF), a commonly undiagnosed indicator of heart failure,3 received U.S. FDA clearance in September 2023 and is currently under review in Europe. Anumana has demonstrated that its ECG-AI technology can be adapted to lower-lead ECG devices while maintaining a high degree of performance. A version of the neural network used in Anumana’s FDA cleared ECG-AI LEF algorithm has shown the algorithm to be effective in detecting low ejection fraction using single-lead wearable ECG devices.4 

InfoBionic.Ai’s MoMe ARC is the first and only continuous 6-lead FDA-cleared platform leveraging leading-edge AI analysis and native business intelligence. MoMeARC is a solution that includes a 4-in-1 Gateway device that seamlessly transitions between 2-day in addition to extended Holter tests, Event and MCT modes remotely, streamlining patient monitoring time and minimizing delays.


InfoBionic.Ai’s digital technology has transformed the efficiency and economics of cardiac remote patient monitoring. The company’s vision for its FDA-cleared third-generation platform, the MoMe ARC®, is to remove the roadblocks hindering virtual and remote diagnosis and decision-making. The Massachusetts-based team of seasoned entrepreneurs has had successful careers in healthcare, IT, medical devices, and mobile technology, and brings specific expertise in remote monitoring and cardiology.

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 collaboration with Mayo Clinic to leverage the clinical and technical expertise of both organizations to develop innovative ECG-AI technology into a clinically meaningful, medical-grade, and easy to use tool for clinicians to advance patient care. Anumana’s software-as-a-medical device (SaMD) ECG-AI™ solutions aim to detect diseases earlier using standard-of-care ECG readings, enabling clinicians to enhance and improve care with real-time AI insights.  

 Anumana’s lead algorithm, ECG-AI™ LEF is now available in the U.S. To learn more about how the algorithm can help clinicians identify low ejection fraction (LEF) earlier and schedule a demo, visit us at ECG-AI LEF. 

https://newsnetwork.mayoclinic.org/discussion/mayo-clinic-launches-new-technology-platform-ventures-to-revolutionize-diagnostic-medicine/

https://infobionic.ai/press/infobionic-enters-know-how-agreement-mayo-clinic/

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.

Attia, Z.I., Harmon, D.M., Dugan, J. et al. Prospective evaluation of smartwatch-enabled detection of left ventricular dysfunction. Nat Med 28, 2497–2503 (2022). https://doi.org/10.1038/s41591-022-02053-1


schoinski@pazangahealth.com                                  

Anumana and InfoBionic.Ai Announce Collaboration to Advance AI-powered Remote Cardiac Telemetry Technology for Early Detection of Cardiac Diseases 

CAMBRIDGE, Mass. – May 14, 2024 Anumana, a leading AI-driven health technology company and portfolio company of nference, today announced the appointment of Harry S. Palmin as chief financial officer (CFO). As a veteran in building, financing, and operating life sciences companies, Palmin brings over 25 years of experience to Anumana’s executive leadership team. In his new role, he will lead financial operations, investor relations, and corporate development activities at Anumana, and guide the company’s strategic growth. In addition to his role as CFO of Anumana, Palmin joins nference as CFO, Ventures.

Palmin's distinguished career includes tenure as CFO at Acer Therapeutics Inc., where he played a pivotal role in the company's successful acquisition by Zevra Therapeutics, Inc. His leadership was instrumental in Acer's public offering and the company’s FDA approval for OLPRUVA™, a treatment for urea cycle disorders. Prior to his role at Acer, Palmin served in multiple executive positions at Novelos Therapeutics, Inc., where he helped transform the company from conceptual stage into a leading public oncology and infectious disease development entity. 

“Harry is a highly skilled and accomplished executive with a proven track record in building successful companies in the life sciences industry,” said Maulik Nanavaty, CEO of Anumana. “I am thrilled to welcome Harry to Anumana at an exciting time for the company, where we are making tremendous progress in pipeline development and commercial traction. I look forward to partnering with him through our next phase of growth.” 

Anumana is at the forefront of revolutionizing healthcare with its groundbreaking ECG-AITM platform that, from standard ECGs at the point of care, enables the identification of hidden cardiovascular diseases for which effective, lifesaving treatments may be available. The ECG-AI platform won the 2024 MedTech Breakthrough Award for “Best New Technology Solution- Cardiology.” 

The company’s lead algorithm, ECG-AI LEF, an FDA Breakthrough Device-designated medical device, recently received FDA clearance for detecting low ejection fraction, a common undiagnosed indicator of heart failure1 and prevalent progressive disease that affects over 6 million people in the U.S. and is associated with a significant total annual healthcare cost.2 Anumana’s expansive development pipeline also includes three additional algorithms with FDA Breakthrough Device designation (pulmonary hypertension, cardiac amyloidosis, and hyperkalemia). The company has multiple ongoing partnerships with leading pharmaceutical companies to further develop and commercialize algorithms in its pipeline.3,4 Anumana also 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.5

“Anumana is one of the most innovative companies in healthcare technology and it is an honor to be joining the organization at such a pivotal time in its growth,” said Palmin. “The progress Anumana has accomplished in just three years since its founding and the potential impact that Anumana’s AI technology platform can make on patient outcomes are inspiring. I am excited to be part of the team and the mission to use pioneering AI technology to unlock the electrical language of the heart and improve patient care.” 

Palmin earned a B.A. in economics and business and an M.A. in international economics and finance from the International Business School at Brandeis University. He also studied at the London School of Economics and the Copenhagen Business School. 

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 collaboration with Mayo Clinic to leverage the clinical and technical expertise of both organizations, to develop innovative ECG-AI technology into a clinically meaningful, medical-grade, and easy-to-use tool for clinicians to advance patient care. Anumana’s software-as-a-medical device (SaMD) ECG-AI™ solutions aim to detect hidden diseases using standard of care ECG readings, enabling clinicians to enhance and improve care with real-time AI insights. 

Anumana’s lead algorithm, ECG-AI™ LEF, is now available in the U.S. To learn more about how the algorithm can help clinicians identify low ejection fraction (LEF) earlier and schedule a demo, visit us at ECG-AI LEF. 

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

nference is unlocking the potential of healthcare data with AI, delivering real-world evidence, insights, and solutions informed by the most comprehensive multimodal data across all therapeutic areas. The company’s extensive de-identified, longitudinal data includes decades of clinical notes along with rich patient histories, vitals, lab tests, radiology images, digital pathology, genomics, and electrophysiology waveforms. Our federated data platform, comprising premier healthcare organizations, including Mayo Clinic, Duke Health, Banner Health, Vanderbilt University Medical Center, and Emory Healthcare, enables advanced research and custom AI model development. With unprecedented access to data from over 40 million patient journeys, our partners can accelerate target discovery, optimize clinical trial design, and enhance lifecycle management. Follow nference on LinkedIn. Visit us at www.nference.com.

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/.

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Anumana Announces issuance of New American Medical Association CPT® Category III codes for Novel ECG AI Analysis of Cardiac Dysfunctions

CAMBRIDGE, Mass. – May 21, 2024 – Anumana, a leading AI-driven health technology company and portfolio company of nference, announced today that it has received the International Organization for Standardization (ISO) 13485 certification for its Quality Management System. This certification, the quality management standard for device manufacturers, indicates that a company has developed robust policies and procedures for the development and manufacture of regulated medical devices. 

Anumana received ISO 13485 certification following an independent third-party certification firm’s rigorous assessment of its Quality Management System. With this certification, Anumana strengthens its ability to provide software-as-a-medical device (SaMD) ECG-AI™ algorithms that consistently meet customer and regulatory requirements. 


“Anumana’s ISO13485 certification is a testament to our commitment to excellence in the development and manufacturing of regulated medical devices that adhere to international standards and requirements,” said David McMullin, Anumana’s chief business officer. “As a rapidly growing international medical device manufacturer, this milestone underscores our leadership in pioneering and bringing to market clinically validated and regulated ECG-AI™ algorithms as SaMDs, validates our capabilities, and enables Anumana to extend the reach of our technology to clinicians and patients worldwide.” 


ECG-AI™ LEF, the company’s FDA-cleared, breakthrough AI algorithm using routine 12-lead ECG data to detect Low Ejection Fraction (LEF), a commonly undiagnosed indicator of heart failure,1 received U.S. FDA clearance in September 2023 and is currently under review in Europe.

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 collaboration with Mayo Clinic to leverage the clinical and technical expertise of both organizations to develop innovative ECG-AI technology into a clinically meaningful, medical-grade, and easy to use tool for clinicians to advance patient care. Anumana’s software-as-a-medical device (SaMD) ECG-AI™ solutions aim to detect hidden diseases using standard-of-care ECG readings, enabling clinicians to enhance and improve care with real-time AI insights. 

Anumana’s lead algorithm, ECG-AI™ LEF is now available in the U.S. To learn more about how the algorithm can help clinicians identify low ejection fraction (LEF) earlier and schedule a demo, visit us at ECG-AI LEF.

Anumana was named one of Fierce MedTech’s Fierce 15 companies for 2022 and received the 2024 Medtech Breakthrough award for Best New Technology Solution, cardiology.  Follow Anumana at anumana.ai and on LinkedIn and Twitter. 

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. 


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

Anumana Demonstrates Global Readiness with Receipt of ISO 13485 Certification

Anumana’s innovative AI algorithms recognized for their transformative potential in cardiology - the first of which is now commercially available

CAMBRIDGE, Mass. – May 9, 2024 – Anumana, Inc., a leading AI-driven health technology company and portfolio company of nference, announced today it has received the 2024 MedTech Breakthrough Award for Best New Technology Solution in the Cardiology category. The recognition is for Anumana’s suite of artificial intelligence (AI)-based electrocardiogram (ECG) interpretation algorithms, with a spotlight on ECG-AI™ LEF, the company’s FDA cleared, breakthrough AI algorithm using routine 12-lead ECG data to detect Low Ejection Fraction (LEF).

Developed in collaboration with Mayo Clinic, Anumana’s ECG-AI LEF represents a paradigm shift in ECG interpretation. 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 underscore the need to identify and manage patients with LEF. ECG-AI LEF is an innovative software-as-a-medical device (SaMD) designed to help clinicians identify LEF in adults earlier by using data from a routine 12-lead ECG, a rapid standard of care test used across primary and specialty care settings. The AI algorithm was clinically validated in a multi-site, retrospective study of 16,000 patients, demonstrating an 84.5% sensitivity and 83.6% specificity.4 Additionally, in a randomized controlled prospective study with 22,641 adults, an investigational version of the algorithm demonstrated the ability to improve primary care clinicians’ diagnoses of LEF by +31% versus standard of care without increasing the overall rate of echocardiogram usage.5  ECG-AI LEF received U.S. FDA clearance in September 2023 and is currently under review in Europe.

Beyond ECG-AI LEF, Anumana has the largest and most robust pipeline of ECG-AI algorithms in development, including three additional FDA Breakthrough Device-designated algorithms (pulmonary hypertension, cardiac amyloidosis, and hyperkalemia), founded on more than six years of pioneering ECG-AI research and development at Mayo Clinic, including nearly 100 studies to date.

“At Anumana, we are committed to developing evidence-based AI algorithms that empower clinicians to uncover diseases earlier and improve patient outcomes,” said Maulik Nanavaty, CEO of Anumana. “We are honored to be recognized by MedTech Breakthrough for our efforts in developing and implementing our cutting edge clinically validated AI algorithms that enhance ECG interpretation. Our ECG-AI algorithm technology represents a groundbreaking shift in the utility of ECG, and we are excited to be at the forefront of improving cardiovascular care with AI technology.”

The MedTech Breakthrough Awards, organized by Tech Breakthrough, an independent, leading market intelligence organization, honors excellence in medical and health related technology, products, services, and people.


ECG-AI LEF is now available in the U.S. To learn more about how the algorithm can help clinicians identify LEF earlier 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 collaboration with Mayo Clinic to leverage the clinical and technical expertise of both organizations to develop innovative ECG-AI technology into a clinically meaningful medical-grade and easy to use tool for clinicians to advance patient care. Anumana’s software-as-a-medical device (SaMD) ECG-AI solutions aim to detect hidden diseases using standard of care ECG readings, enabling clinicians to enhance and improve care with 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.

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.     Anumana data on file (NCT04963218).

5.      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.

Pazanga Health Communications for Anumana

Anumana’s ECG-AI™ Algorithms Honored with 2024 MedTech Breakthrough Award for “Best New Technology Solution-Cardiology”

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.

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 in the News

Data from Anumana’s New Study Show AI Algorithm Has the Potential to Detect Pulmonary Hypertension Early Using ECG Data

Anumana and InfoBionic.Ai Announce Collaboration to Advance AI-powered Remote Cardiac Telemetry Technology for Early Detection of Cardiac Diseases

Anumana Demonstrates Global Readiness with Receipt of ISO 13485 Certification

Anumana Appoints Harry S. Palmin as CFO

Anumana’s ECG-AI™ Algorithms Honored with 2024 MedTech Breakthrough Award for “Best New Technology Solution-Cardiology”

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