BrightHeart Secures FDA Clearance for First AI Software Revolutionizing Prenatal Fetal Heart Ultrasound Evaluations

PARIS--(BUSINESS WIRE)--BrightHeart, a leading AI innovator in obstetric and pediatric cardiology technology, announces it has received FDA 510(k) clearance for its first artificial intelligence software, designed to transform prenatal ultrasound evaluations of the fetal heart. This milestone marks a significant breakthrough in one of the most challenging and critical areas of prenatal care.