Anumana announced that it received FDA 510(k) clearance for its AI-powered ECG-AI LEF medical device.
Cambridge, Massachusetts-based Anumana, an Nference portfolio company, worked in collaboration with Mayo Clinic. They designed the breakthrough medical device to detect low ejection fraction (LEF) in patients at risk of heart failure. The company’s pulmonary hypertension (PH) early detection algorithm also won FDA breakthrough device designation last year.
Developed as software-as-a-medical device (SaMD), the algorithm screens LEF in adults at risk for heart failure. It uses data from a routine 12-lead electrocardiogram (ECG). Anumana developed it using research from Mayo Clinic that included more than 100,000 ECG and echocardiogram data pairs. The data came from more than 25 studies evaluating more than 40,000 patients in the U.S. and abroad.
Further data from 16,000 racially diverse patients saw the algorithm achieve its primary endpoint with 84.5% sensitivity and 83.6% specificity. A Mayo Clinic trial evaluated 22,641 adults and saw that ECG-AI LEF implementation improved LEF diagnosis by 31% versus standard of care. It also didn’t increase the overall rate of echocardiogram usage.
Dr. Paul Friedman, chair of Mayo Clinic’s Dept. of Cardiovascular Medicine, said Anumana’s technology fills “an important unmet need.” He said it enables the identification of an otherwise hidden disease. Friedman also serves as chair of Anumana’s board.
“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. “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.”