BrightHeart’s AI Software for Fetal Heart Ultrasound Evaluation Cleared by FDA

November 18, 2024—BrightHeart SAS, a Paris, France–based developer of obstetric and pediatric cardiology technology, announced it has received FDA 510(k) clearance for its artificial intelligence (AI) software for prenatal ultrasound evaluation of the fetal heart and is now poised for a United States commercial launch.

According to the company, BrightHeart’s technology automates key aspects of the evaluation process to save time and improve accuracy in resource-constrained practices. It is designed to integrate into existing workflows, reducing the burden on sonographers and OB/GYN practitioners.

The BrightHeart software enables clinicians to improve the detection of morphological abnormalities suggestive of congenital heart defects (CHDs). The AI-based solution addresses the challenges faced by fetal heart ultrasound examinations in detecting CHDs, including misdetection or delayed diagnosis leading to missed opportunities for life-saving interventions, stated the company.

The press release noted that the BrightHeart software builds on an idea by Marilyne Levy, MD, and Bertrand Stos, MD, fetal cardiologists based in Paris and cofounders of the company. BrightHeart is led by CEO Cécile Dupont and Chairman Michael Butchko. The company is privately held and part of Sofinnova MD Start, a Sofinnova Partners medical device accelerator.