The software was found to improve CHD detection by more than 15% and provide conclusions in 98.8% of exams.

BrightHeart’s FDA-cleared AI software showed promise in improving the diagnostic rate of identifying congenital heart defects (CHDs) during prenatal ultrasounds, according to findings from two studies presented at the Society for Maternal-Fetal Medicine (SMFM) 2025 Pregnancy Meeting. Brightheart's solution improved detection rates with a 15.3% increase in sensitivity and boosted efficiency, cutting reading time by 18% among specialists.

AI improves detection of major congenital heart defects (CHDs) on prenatal ultrasound, suggest findings presented January 30 at the Annual Pregnancy Meeting of the Society for Maternal-Fetal Medicine (SMFM) in Denver, CO.

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.

PARIS–(BUSINESS WIRE)–BrightHeart, a global leader in artificial intelligence (AI) solutions for obstetrics and pediatric cardiology, presented two groundbreaking studies during the oral plenary and concurrent sessions on January 30th at the Society for Maternal-Fetal Medicine (SMFM) 2025 Pregnancy Meeting, held in Aurora, Colorado.

In a recent interview with Contemporary OB/GYN, Jennifer Lam-Rachlin, MD, a maternal-fetal medicine specialist and director of fetal echocardiography at Carnegie Imaging for Women, discussed the role of artificial intelligence (AI) in improving the detection of major congenital heart defects (CHDs)

Denver, Colo. ― Congenital heart defects (abnormalities of the heart that are present at birth) are the most common type of birth defect and, according to the Centers for Disease Control and Prevention, about 1 in 4 babies born with a heart defect has a diagnosis that is severe enough to require surgery or other medical intervention within the first year of life. Despite advances in prenatal care, the detection rate of congenital heart defects during routine ultrasounds remains suboptimal.

For children born with congenital heart defects (CHDs), early diagnosis before birth is essential to ensure that the baby will receive optimized care after delivery for the best possible outcome. However, only 34% of congenital heart defects are detected prenatally.

PARIS--(BUSINESS WIRE)--BrightHeart, a leading AI innovator in obstetric and pediatric cardiology technology, announced today that the groundbreaking results of two key studies of the company’s Artificial Intelligence (AI) software will be presented at the Society for Maternal-Fetal Medicine 2025 Pregnancy Meeting taking place January 27th-February 1st in Aurora, Colorado.

PARIS--(BUSINESS WIRE)--BrightHeart, a leading AI innovator in obstetric and pediatric cardiology technology, announces it has received FDA 510(k) clearance for its first artificial intelligence software, designed to transform prenatal ultrasound evaluations of the fetal heart. This milestone marks a significant breakthrough in one of the most challenging and critical areas of prenatal care.

PARIS--(BUSINESS WIRE)--BrightHeart, a leading AI innovator in obstetric and pediatric cardiology technology, is delighted to announce the appointment of Michael Butchko as the new Chairman of the Board, succeeding Anne Osdoit.

Cécile Dupont, Partner in the Sofinnova MD Start Strategy, was selected as one of In Vivo’s Rising Leaders, which is a list of “entrepreneurs and innovators from across the world who represent the next wave of creativity in healthcare.”

Paris, France, May, 31, 2023 — BrightHeart, a Paris-based medical technology company developing unique artificial intelligence software focused on improving the detection of congenital heart defects in fetuses, announced today that it has raised €2 million in seed financing from Sofinnova Partners, a leading European life sciences venture capital firm based in Paris, London, and Milan. The funds are being deployed to bolster the development of the BrightHeart technology, prepare its regulatory submission(s), and facilitate the company’s expansion.