Anumana ECG-AI LEF Algorithm Receives FDA Clearance

October 2, 2023—Anumana, Inc. announced it received 510(k) clearance from the FDA for ECG-AI LEF, an artificial intelligence (AI)–powered medical device to detect low ejection fraction (LEF) in patients at risk of heart failure using data from a routine 12-lead electrocardiogram (ECG).

Anumana is an Nference portfolio company. The company was founded by Nference in partnership with the Mayo Clinic to leverage the clinical and technical expertise of both organizations to develop ECG-AI technology from an investigational resource to a clinical tool for clinicians.

Anumana’s software-as-a-medical device solutions aim to detect hidden diseases using ECG-AI algorithms to enhance and improve interventional procedures through real-time AI insights.

According to Anumana, the algorithm was developed based on research from Mayo Clinic in Rochester, Minnesota, using > 100,000 ECGs and ECG data pairs from unique patients. It has been clinically tested in > 25 studies involving > 40,000 patients in the United States and internationally.

As noted in the press release, Anumana’s ECG-AI LEF was clinically validated in a multicenter, retrospective clinical study of 16,000 racially diverse patients, achieving its primary endpoint with 84.5% sensitivity and 83.6% specificity. ECG-AI LEF achieved an area under the receiving operating characteristic curve of 0.932, demonstrating an ability to differentiate between LEF and ejection fraction > 40% extremely well (a score ≥ 0.90 is considered excellent) and better than most tests currently used in heart failure standard of care.

Additionally, the Mayo Clinic conducted the prospective, randomized controlled EAGLE clinical trial that 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. The study demonstrated that ECG-AI LEF implementation improved clinician’s ability to diagnose LEF by 31% versus standard of care without increasing the overall rate of echocardiogram usage.

Anumana noted that its pipeline of algorithms includes three additional algorithms (pulmonary hypertension, cardiac amyloidosis, and hyperkalemia) that have received FDA Breakthrough Device designation.

Anumana noted that reimbursement for ECG-AI received 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.

“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,” commented Paul Friedman, MD, in the company’s press release. “It allows identification of otherwise hidden disease, for which many effective, lifesaving treatments are available—once the presence of the disease is known.” Dr. Friedman serves as Chair of Anumana’s Board of Advisors and Chair of the Department of Cardiovascular Medicine at Mayo Clinic.