Anumana has received the US Food and Drug Administration (FDA) 510(k) clearance for its ECG-AI LEF algorithm for the detection of low ejection fraction (LEF) in patients who are prone to heart failure.

Developed in partnership with Mayo Clinic, ECG-AI LEF is an artificial intelligence (AI)-driven software-as-a-medical device (SaMD).

Anumana designed the algorithm to screen LEF using data from a standard 12-lead electrocardiogram (ECG), which is a fast and common test that is employed in primary as well as speciality care.

The US-based health technology company, which was founded by nference in partnership with Mayo Clinic, created the algorithm using over 100,000 ECG and echocardiography data sets from patients.

The algorithm is said to have been clinically tested in more than 25 trials featuring more than 40,000 patients in the US and other countries.

In a multi-site, retrospective clinical trial including 16,000 racially diverse individuals, ECG-AI LEF was clinically validated, reaching its primary endpoint with an 84.5% sensitivity and 83.6% specificity.

In addition, the prospective, randomised, controlled EAGLE study by Mayo Clinic assessed 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.

As per the results, the LEF detection device improved clinicians’ ability to diagnose LEF by 31% compared to standard of care without increasing the overall rate of echocardiogram usage.

The device can be quickly linked with a variety of ECG information management systems or with a patient’s electronic health record through the firm’s web-based ECG Viewer to help clinical decision-making, the health technology company said.

Anumana and nference co-founder and CEO Murali Aravamudan said: “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 US and globally to empower clinicians and enhance real-world clinical care.”