BrightHeart, a company specializing in artificial intelligence (AI) solutions for obstetrics and pediatric cardiology, has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for updates to its BrightHeart platform.

The FDA nod covers the capability for clinicians to access the BrightHeart analysis in real-time through a cart-side tablet.

The company’s AI tech targets the challenge of screening for congenital heart defects (CHDs). The first-of-its-kind screening tool applies AI to flag findings on structural markets that might be suggestive of CHDs.

“Our product expansion builds upon the success of our initial pilot experience, bringing real-time feedback directly to the clinicians to streamline the workflow and enhance accuracy,” said Cécile Dupont, BrightHeart CEO and partner at Sofinnova Partners. “Our team rapidly executed from concept to pilot implementation of the BrightHeart tablet in clinics, and we were thrilled to achieve clearance through our first Special 510(k) submission within just a few months.”

The company’s software obtained its first 510(k) clearance in November 2024. The company is preparing to launch BrightHeart on a limited basis in an exclusive set of clinics.

“The clinician reception to the BrightHeart tablet has been very positive during our pilot experience,” said Dr. Jennifer Lam-Rachlin, Maternal Fetal Medicine Assistant Professor at Icahn School of Medicine at Mount Sinai Hospital/Mount Sinai West Hospital, Director of Fetal Echocardiography at Carnegie Imaging for Women. “With real-time alerts on structural markers, BrightHeart supports efficiency in the fetal heart evaluation by bolstering the analysis and documentation for both normal and abnormal scans – ultimately boosting confidence and consistency in the exam room.”