BrightHeart announced today that it received FDA 510(k) clearance for its first AI software for prenatal ultrasound evaluations of the fetal heart.
Paris-based BrightHeart designed its AI to address the challenges of detecting congenital heart defects (CHDs) in newborns. The company says misdetection or delayed diagnosis often leads to severe consequences, including missed opportunities for life-saving interventions.
The AI platform enables clinicians to improve the detection of morphological abnormalities suggestive of CHDs in resource-constrained practices.
BrightHeart designed its technology to integrate seamlessly into existing workflows and reduce the burden on sonographers and OB/GYNs. The software automates key aspects of the evaluation process to save time and improve accuracy, the company said.
According to the company, FDA clearance comes as part of the company’s “unprecedented pace,” as pediatric cardiologists founded BrightHeart just two years ago. With FDA clearance secured, the company plans to execute a U.S. launch and operations scale in the future.
“Fetal heart assessments are among the most technically demanding aspects of prenatal ultrasound,” said Cécile Dupont, BrightHeart CEO. “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.”
