BrightHeart Secures FDA Clearance for First AI Software Revolutionizing Prenatal Fetal Heart Ultrasound Evaluations
Paris, France – November 18th, 2024 – 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 1 in 100 newborns. However, misdetection or delayed diagnosis can lead to severe consequences, including missed opportunities for life-saving interventions. BrightHeart’s AI software offers an innovative solution to these challenges, enabling clinicians to improve the detection of morphological abnormalities suggestive of CHDs, in resource-constrained practices.
