BrightHeart has gained a further 510(k) clearance from the US Food and Drug Administration (FDA) for its AI-based prenatal congenital heart defect (CHD) screening platform. Building on the initial ...

We may make money when you click on links to our partners. Learn More. The FDA has granted 510(k) clearance to BrightHeart, a Paris-based AI innovator specializing in obstetric and pediatric ...