BrightHeart, a Paris-based AI company focused on obstetrics and pediatric cardiology, has demonstrated breakthrough results in improving detection of congenital heart defects (CHDs) during prenatal ultrasounds. The company also recently received FDA clearance for its innovative AI technology.
In a study of 200 prenatal ultrasound exams reviewed by 14 US and European physicians, BrightHeart’s AI software increased detection sensitivity by 15.3% while reducing reading time by 18% among both OB-GYNs and MFM specialists.
A larger study, examining 877 ultrasound exams from 11 centers internationally, showed the AI software could provide conclusions for 98.8% of exams, with a sensitivity of 98.7% and specificity of 97.7% in identifying signs associated with severe CHD. This advancement addresses a significant clinical need, as currently up to 70% of CHD cases go undetected during routine prenatal ultrasounds.
“This technology has the power to transform clinical practice, making expert-level diagnostics accessible to all, regardless of location or specialist availability,” said Cécile Dupont, BrightHeart CEO and Partner at Sofinnova Partners.
Dr. Jennifer Lam-Rachlin, Maternal Fetal Medicine Assistant Professor at Icahn School of Medicine at Mount Sinai Hospital/Mount Sinai West Hospital, added: “Our early exposure to the BrightHeart AI software through these research studies has already had a positive impact on our center. As AI continues to transform ultrasound care, BrightHeart’s findings highlight its ability to optimize fetal heart evaluation, streamline workflows, and improve prenatal diagnostics.”
The company was founded based on over a decade of fetal cardiology training expertise from Dr. Marilyne Levy and Dr. Bertrand Stos, two leading fetal cardiologists in Paris.
