PARIS– 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.
Fetal heart ultrasounds exams are essential for detecting congenital heart defects (CHDs), which are the most common type of birth defect, affecting nearly 1 in 100 newborns. However, misdetection or delayed diagnosis can lead to severe consequences, including missed opportunities for life-saving interventions. 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.
“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.”
BrightHeart’s technology is designed to integrate seamlessly into existing workflows, reducing the burden on overworked sonographers and OB/GYNs. By automating key aspects of the evaluation process, the software has the ability to save time and improve accuracy, in increasingly resource-constrained practices.
Founded just two years ago, on an idea by pediatric cardiologists, Dr. Marilyne Levy and Dr. Bertrand Stos, BrightHeart has achieved this milestone at an unprecedented pace, showcasing the dedication of its expert team and the power of cutting-edge AI technology. “We’ve moved from concept to FDA clearance in record time, demonstrating the potential of our product and the agility and commitment of our team,” added Cécile Dupont.
With 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.
“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.”
