Dive Brief:

• Anumana has received 510(k) clearance for a software-as-a-medical device (SaMD) that screens for low ejection fraction (LEF) in patients at risk of heart failure.
• Developed in collaboration with Mayo Clinic, the algorithm analyzes 12-lead electrocardiograms (ECGs) to identify LEF, a weakness that indicates a patient may be developing heart failure.
• Anumana secured Food and Drug Administration clearance of the SaMD after linking it to 83.6% specificity and 84.5% sensitivity in a retrospective clinical study of 16,000 patients.

Dive Insight:

Guideline-recommended therapies can reduce the risk of heart failure progression and death in people with LEF. Healthcare professionals can detect LEF with echocardiography, but many cases go undiagnosed because the resource requirements of the imaging test make it impractical to screen widely. Artificial intelligence (AI) that supports screening for LEF could improve outcomes by enabling timely treatment.

Massachusetts-based Anumana, founded by health tech company nference in partnership with Mayo Clinic, has worked to develop such an approach. The result is ECG-AI LEF, an AI-powered medical device that recently received 510(k) clearance for use in the detection of LEF in patients at risk of heart failure.

“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, It allows identification of otherwise hidden disease, for which many effective, lifesaving treatments are available – once the presence of the disease is known,” Mayo Clinic’s Paul Friedman, chair of the Department of Cardiovascular Medicine, said in a statement.

Friedman, chair of Anumana’s board of advisers, co-authored a Nature Medicine paper about a clinical trial of an investigational version of the algorithm in 2021. The prospective, randomized, controlled trial found implementing the algorithm increased the diagnosis of LEF by 32% relative to usual care without increasing the overall rate of echocardiogram usage.

Anumana received codes for ECG-AI from the American Medical Association last year, clearing a barrier to the use and reimbursement of its newly cleared test. The product is designed to integrate with ECG information management systems to support adoption.