BrightHeart, a leading AI innovator in obstetric and pediatric cardiology technology, 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.

Fetal heart ultrasound exams are essential for detecting congenital heart defects (CHDs). BrightHeart’s AI software offers an innovative solution to these challenges, enabling clinicians to improve the detection of morphological abnormalities suggestive of CHDs in resource-constrained practices.

BrightHeart’s technology integrates into existing workflows, reducing the burden on overworked sonographers and OB/GYNs. By automating key aspects of the evaluation process, the software can save time and improve accuracy. 

“Fetal heart assessments are among the most technically demanding aspects of prenatal ultrasound,” said Cécile Dupont, BrightHeart CEO and a Partner at Sofinnova Partners’ medtech accelerator, MD Start. “Our AI-powered solution not only assists clinicians in detecting signs of potential abnormalities earlier but also enhances their confidence in confirming normal findings, which is equally critical for the peace of mind of expectant families.”

Dr. Marilyne Levy and Dr. Bertrand Stos founded the company two years ago. Since then, BrightHeart has achieved this milestone, showcasing the dedication of its team and the power of its AI technology.

“Resource constraints and workforce shortages are critical challenges in prenatal care, and we believe BrightHeart is uniquely positioned to address them,” said Michael Butchko, Chairman of BrightHeart. “In this next phase, we aim to deliver our transformative technology to clinicians and expectant families, making a measurable impact on prenatal care outcomes.”

With its FDA clearance secured, BrightHeart is poised for its U.S. commercial launch, driving efforts to scale operations, enter the market, and showcase its groundbreaking solution in clinics and hospitals across the country.