BrightHeart earned its second FDA 510(k) clearance for updates to its BrightHeart platform, an AI-powered digital screening tool for congenital heart defects (CHDs).
The obstetrics and pediatric cardiology medical device company, based in Paris, announced yesterday that it received the new clearance for the addition of a cart-side tablet that clinicians can use during fetal heart ultrasound evaluations. In November 2024, the FDA granted the company its initial 501(k) clearance for its AI software.
The AI platform is designed to integrate into existing workflows and flag structural markers associated with CHDs. Up to 70% of CHDs go undetected by clinicians conducting routine prenatal ultrasound exams, according to BrightHeart. And the company hopes to change that with this digital screening tool.
The BrightHeart tablet was piloted in clinics, where it received positive feedback.
“With real-time alerts on structural markers, BrightHeart supports efficiency in the fetal heart evaluation by bolstering the analysis and documentation for both normal and abnormal scans — ultimately boosting confidence and consistency in the exam room,” said Dr. Jennifer Lam-Rachlin, maternal fetal medicine assistant professor at the Icahn School of Medicine at Mount Sinai Hospital/Mount Sinai West Hospital and director of fetal echocardiography at Carnegie Imaging for Women, in the news release announcing the latest FDA clearance.
In January, BrightHeart presented the results of two studies of its software’s clinical results at the Society for Maternal-Fetal Medicine (SMFM) 2025 Pregnancy Meeting held in Aurora, Colorado. The first study found that the AI software improved detection rates with a 15.3% increase in sensitivity. The software was able to provide clinicians with conclusions for the majority of exams (98.8%), according to the results of the second study.
BrightHeart is a part of a medical device accelerator, Sofinnova MD Start, run by European venture capital firm Sofinnova Partners.
Following the company’s product expansion and FDA clearances, it is gearing up for a limited launch in a number of clinics.
Carrie Pallardy is a freelance writer and editor based in Chicago. She has more than a decade of experience writing and reporting in the healthcare space.
