FDA Clears Emerging AI-Enabled Software for Cardiac Ultrasound

The Food and Drug Administration (FDA) has granted 510(k) clearance for the AI-powered echocardiography HeartFocus software, which reportedly allows health-care providers with limited echocardiography experience to obtain heart scans.

In addition to offering quality and precision indicators via real-time feedback, the HeartFocus software provides automated recording of top quality clips for 10 ultrasound cardiac reference views, according to DESKi, the manufacturer of the software.

In a prospective multicenter trial, presented recently at the American College of Cardiology (ACC) conference, researchers found that health-care providers with limited echocardiography experience who used the HeartFocus software were able to achieve greater than 85 percent agreement with expert sonographers in assessing 12 echocardiographic parameters.

“The clinical trial results and subsequent FDA clearance mark a major step forward in making echocardiography more accessible in the community. Proving that it can successfully guide any healthcare professional to capture high-quality heart scans, HeartFocus will help patients get diagnosed sooner and move more quickly toward the treatment they need,” posited Varinder P. Singh, M.D., the chair of the Department of Cardiology at Lenox Hill Hospital in New York, and senior vice president and executive director of global and international health for Northwell Health.