Artificial IntelligenceBrightHeart Secures FDA Clearance for First AI Software Revolutionizing Prenatal Fetal Heart Ultrasound Evaluations
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. Fetal heart ultrasounds exams are essential for detecting congenital heart defects (CHDs), which are the most common type of birth defect, affecting nearly...