Anumana, Inc., a prominent player in the field of AI-driven health technology and a subsidiary of nference, in partnership with Mayo Clinic, is thrilled to announce that it has received clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking medical device known as ECG-AI LEF. This innovative artificial intelligence (AI)-powered device is designed to detect low ejection fraction (LEF) in patients who are at risk of heart failure.

Low ejection fraction, characterized by a weakened heart pump, is a significant and often asymptomatic indicator of heart failure that frequently goes undiagnosed. The growing prevalence of heart failure and its associated adverse effects on health, mortality rates, hospital readmissions, and societal costs highlight the urgent need for early identification and management of patients with LEF.

Dr. Paul Friedman, Chair of the Department of Cardiovascular Medicine at Mayo Clinic in Rochester, Minnesota, and Chair of Anumana's Board of Advisors, emphasized the importance of ECG-AI LEF, stating, "Anumana’s ECG-AI LEF fills an important unmet need – the lack of an easily accessible point-of-care, noninvasive, and cost-effective tool to screen for a weak heart pump. 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 collaboration with Mayo Clinic, Anumana's ECG-AI LEF is a groundbreaking software-as-a-medical device (SaMD) designed to screen for LEF in adults at risk of heart failure by analyzing data from a routine 12-lead electrocardiogram (ECG), a widely used and rapid test in both primary and specialty care. This algorithm, based on pioneering research from Mayo Clinic, was developed using data from over 100,000 pairs of ECG and echocardiogram data from diverse patients and has undergone clinical testing in more than 25 studies involving over 40,000 patients in the United States and internationally.

Anumana's ECG-AI LEF was rigorously validated in a large-scale, multi-site, retrospective clinical study involving 16,000 patients of various racial backgrounds. It achieved its primary endpoint with an impressive 84.5% sensitivity and 83.6% specificity. Furthermore, it demonstrated an exceptional AUROC of 0.932, indicating its remarkable ability to distinguish between LEF and ejection fraction (EF) >40%. This performance surpasses most existing tests used in standard heart failure care.

In a groundbreaking study known as the EAGLE study, conducted by Mayo Clinic, an investigational version of the algorithm was assessed in the routine clinical care of 22,641 adults by 120 primary care teams across 45 clinics and hospitals. The results showed that implementing ECG-AI LEF led to a 31% improvement in the diagnosis of LEF by clinicians compared to the standard of care, without increasing the overall rate of echocardiogram usage.

ECG-AI LEF is just one of Anumana's extensive pipeline of algorithms, including three other FDA breakthrough device designation algorithms for pulmonary hypertension, cardiac amyloidosis, and hyperkalemia. These innovations are built upon over six years of pioneering ECG-AI research and development at Mayo Clinic, supported by nearly 100 peer-reviewed publications to date.

Murali Aravamudan, co-founder and CEO of Anumana and nference, spoke about the company's journey, saying, "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. 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's primary focus is on accelerating the adoption of ECG-AI technology in clinical practice, further developing and commercializing its innovative healthcare technologies. The recently FDA-cleared ECG-AI LEF can be seamlessly integrated with various ECG information management systems or directly with a patient's electronic health record through Anumana's web-based ECG Viewer, facilitating clinical decision-making.

Anumana has played a pivotal role in securing reimbursement for ECG-AI, receiving approval for two Category III CPT® codes from the American Medical Association in 2022. These codes are now available and are designed to simplify the use, adoption, and potential reimbursement of emerging technologies in clinical workflows.

To learn more about ECG-AI LEF and to schedule a demonstration, please visit Anumana's website at anumana.ai.

 

Source: businesswire.com

Report Abuse