FDA Clears AI Software for Fetal Heart Ultrasound Assessment

The Food and Drug Administration (FDA) has granted 510(k) clearance for BrightHeart’s artificial intelligence (AI)-enabled software, which may bolster ultrasound detection of congenital heart defects (CHDs) that have been estimated to occur in one of every 100 newborns.

Employing AI algorithms that were developed on over 90,000 ultrasound exams, BrightHeart’s AI software provides automated video stream analysis and detailed assessment of fetal heart morphology, which detects or rules out findings suggestive of CHDs, according to BrightHeart.

The company says the software also offers AI assessment as to the completeness of fetal heart ultrasound exams and facilitates smooth integration into existing ultrasound workflows.

“Fetal heart assessments are among the most technically demanding aspects of prenatal ultrasound,” said Cécile Dupont, the CEO of BrightHeart. “Our AI-powered solution not only assists clinicians in detecting signs of potential abnormalities earlier but also enhances their confidence in confirming normal findings, which is equally critical for the peace of mind of expectant families.”