The FDA has granted 510(k) clearance to BrightHeart, a Paris-based AI innovator specializing in obstetric and pediatric cardiology, for its first AI software designed to transform prenatal ultrasound evaluations of the fetal heart.
This clearance marks a critical step forward in addressing the complex challenges of detecting congenital heart defects (CHDs), the most common congenital disability affecting approximately one in 100 newborns—one percent of annual births in the U.S., or about 40,000 babies. This milestone, achieved by the company in just two years since its founding, aims to advance prenatal care by improving diagnostic accuracy and efficiency.
CHDs account for nearly 3 percent of infant deaths due to birth defects. Early detection of CHD is important for life-saving interventions, but current prenatal care practices often face limitations, such as resource constraints, workforce shortages, and the technical demands of fetal heart assessments, which can lead to misdiagnosis or delayed diagnosis. BrightHeart’s AI technology automates vital aspects of fetal heart assessments, improving the detection of morphological abnormalities indicative of CHDs while reducing the workload on overburdened sonographers and OB/GYNs while improving diagnostic confidence.
“One of the most technically challenging tasks in prenatal ultrasound is evaluating fetal heart health,” said Cécile Dupont, CEO of BrightHeart. “Our AI-driven solution not only aids clinicians in identifying early signs of potential issues but also boosts their confidence in confirming normal results, which is equally essential for providing reassurance to expectant families.”
Workforce shortages and resource constraints have long plagued prenatal care providers. BrightHeart’s AI-charged software offers clinics and hospitals an efficient solution that addresses these challenges. The company is preparing for its U.S. commercial launch with FDA clearance secured. BrightHeart plans to scale its operations and introduce its technology to clinics and hospitals nationwide, improving pregnancy outcomes through better detection and planning.
“Prenatal care faces significant challenges due to resource limitations and workforce shortages, and BrightHeart is uniquely equipped to tackle these issues,” said Michael Butchko, Chairman of BrightHeart. “In this next phase, our goal is to deliver our transformative technology to clinicians and families, driving meaningful improvements in prenatal care outcomes.”
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