BrightHeart

BrightHeart SAS is a Paris-based medical technology company founded in October 2022 that operates in the digital health sector, focusing on obstetric and pediatric cardiology. The company was established based on an idea from two leading French fetal cardiologists, Dr. Marilyne Levy and Dr. Bertrand Stos, who brought over a decade of experience and a proprietary database of more than 20,000 fetal ultrasound exams to the venture. BrightHeart is part of the Sofinnova MD Start accelerator program, which partners with entrepreneurs to develop disruptive medical devices.

In May 2023, the company secured €2 million in seed financing from Sofinnova Partners to advance the development of its technology, prepare for regulatory submissions, and expand its team. A significant milestone was achieved in November 2024, when BrightHeart received its first FDA 510(k) clearance for its AI software. This was followed by a second clearance in May 2025 for a platform expansion allowing real-time analysis on a cart-side tablet, and a third clearance that same month for its B-Right Views device.

BrightHeart's core business is the development of artificial intelligence software designed to improve the detection of congenital heart defects (CHDs) in fetuses during routine ultrasound screenings. The company's B-Right AI Platform serves clinicians, sonographers, and OB/GYNs by providing real-time, expert-level interpretation of fetal heart ultrasound exams, which are notoriously complex. The software integrates into existing ultrasound workflows, analyzing video streams to automatically detect required views, confirm exam completeness, and flag potential structural abnormalities suggestive of CHDs. This aims to address the low prenatal detection rate of CHDs, which stands as low as 30%.

By enhancing diagnostic accuracy and streamlining workflows, the technology is designed to improve newborn outcomes through anticipated delivery care and early intervention. The platform provides clinicians with decision support, reduces the need for repeat scans, and offers reassurance to expectant families when results are normal. Following its recent FDA clearances, BrightHeart is preparing for a limited market release and a commercial launch in the United States, targeting clinics and hospitals.

Keywords: fetal cardiology, artificial intelligence, medical imaging, congenital heart defects, ultrasound software, prenatal screening, digital health, MedTech, obstetrics, pediatric cardiology, FDA clearance, B-Right AI Platform, Sofinnova Partners, fetal heart assessment, diagnostic software, real-time analysis, clinical decision support, sonography, OB/GYN tools, prenatal care, medical device accelerator