Paris– BrightHeart, a Paris-based developer of AI-powered tools for obstetrics and pediatric cardiology, has received its second FDA 510(k) clearance, this time for a major upgrade that enables its fetal heart analysis platform to be accessed in real time via a cart-side tablet. The update allows clinicians to receive on-the-spot insights during routine ultrasounds, marking a significant step toward more accessible and consistent prenatal heart screenings.
The expanded platform aims to address one of the most persistent challenges in prenatal care: the underdiagnosis of congenital heart defects (CHDs), which remain the most common birth defect. Despite their prevalence, up to 70% of CHDs go undetected during standard ultrasounds due to the complexity of fetal heart evaluations. BrightHeart’s AI-driven software analyzes structural markers to flag potential abnormalities, acting as a digital assistant to sonographers and maternal-fetal medicine specialists.
“Our product expansion builds upon the success of our initial pilot experience, bringing real-time feedback directly to the clinicians to streamline the workflow and enhance accuracy,” said Cécile Dupont, CEO of BrightHeart and a partner at Sofinnova Partners. “We were thrilled to achieve clearance through our first Special 510(k) submission within just a few months.”
The tablet interface offers a user-friendly extension of BrightHeart’s core technology, providing alerts and analysis during the scan itself. Early clinical feedback has been enthusiastic, with physicians praising its ability to improve consistency and boost diagnostic confidence.
“With real-time alerts on structural markers, BrightHeart supports efficiency in fetal heart evaluation by bolstering both the analysis and documentation—ultimately boosting confidence in the exam room,” said Dr. Jennifer Lam-Rachlin, Director of Fetal Echocardiography at Carnegie Imaging for Women and Assistant Professor of Maternal Fetal Medicine at Mount Sinai.
Dr. Sara Garmel, Perinatologist and Founding Partner at Michigan Perinatal Associates, emphasized the tool’s clinical impact: “Heart defects are so hard to detect, and so devastating if missed. By surfacing alerts during the scan, BrightHeart helps bring greater structure and efficiency to fetal heart exams, supporting earlier and more accurate detection.”
Following its dual FDA clearances, BrightHeart is preparing a limited market release of the tablet-enabled platform, aiming to deploy the technology across a select group of clinics. The company is inviting clinicians, researchers, and health care partners to collaborate in its mission to elevate standards in maternal-fetal health.
