Anumana has received US Food and Drug Administration (FDA) 510(k) clearance for its artificial intelligence (AI)-powered medical device, ECG-AI LEF, for the detection of low ejection fraction (LEF).
LEF is an asymptomatic and generally undiagnosed heart failure indicator and the device is intended for LEF detection in patients with heart failure risk.
Anumana has worked with the Mayo Clinic to develop the software-as-a-medical device (SaMD) for screening LEF in adults using data from a routine 12-lead electrocardiogram (ECG).
The algorithm is based on Mayo Clinic research and has been developed using more than 100,000 ECG and echocardiogram data pairs from unique patients.
It has been clinically assessed in more than 25 studies, which involved more than 40,000 patients in the US and globally.
The device attained the primary endpoint with 84.5% sensitivity and 83.6% specificity in a trial of 16,000 racially diverse patients.
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It was clinically validated in this multi-site, retrospective study.
Furthermore, the investigational version of the algorithm has been evaluated in the randomised, prospective, controlled EAGLE study by the Mayo Clinic. It was studied in the routine clinical care of 22,641 adult subjects by 120 primary care teams from 45 hospitals or clinics.
The trial showed that ECG-AI LEF deployment enhanced the ability of the clinician to diagnose LEF by 31% against the standard of care without increasing the overall echocardiogram usage rate.
The company has already received breakthrough device designation from the FDA for three additional algorithms for the detection of hyperkalaemia, cardiac amyloidosis and pulmonary hypertension.
Anumana CEO and co-founder 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.”