BrightHeart has received FDA 510(k) clearance for its artificial intelligence software designed for prenatal ultrasound evaluations of the fetal heart. The technology aims to support the detection of congenital heart defects (CHDs), which affect nearly 1 in 100 newborns.
“Fetal heart assessments are among the most technically demanding aspects of prenatal ultrasound,” said Cécile Dupont, BrightHeart CEO and a Partner at Sofinnova Partners’ medtech accelerator, MD Start. “Our AI-powered solution not only assists clinicians in detecting signs of potential abnormalities earlier but also enhances their confidence in confirming normal findings, which is equally critical for the peace of mind of expectant families.”
The software integrates into existing workflows to support sonographers and OB/GYNs in evaluating fetal hearts. The Paris-based company developed the technology based on work by pediatric cardiologists Dr. Marilyne Levy and Dr. Bertrand Stos.
“Resource constraints and workforce shortages are critical challenges in prenatal care, and we believe BrightHeart is uniquely positioned to address them,” said Michael Butchko, Chairman of BrightHeart. “In this next phase, we aim to deliver our transformative technology to clinicians and expectant families, making a measurable impact on prenatal care outcomes.”
Following the FDA clearance, BrightHeart plans to launch commercially in the United States, focusing on implementing its solution in clinics and hospitals across the country.
