BrightHeart, an AI innovator in obstetric and pediatric cardiology, has announced FDA 510(k) clearance for its AI software designed to improve prenatal ultrasound evaluations of the fetal heart. This clearance marks a significant advancement in prenatal care, potentially improving the detection of congenital heart defects (CHDs).
Addressing Critical Needs in Prenatal Care
Fetal heart ultrasounds are crucial for detecting CHDs, the most common type of birth defect, affecting approximately 1 in 100 newborns. Misdetection or delayed diagnosis can lead to severe consequences, including missed opportunities for life-saving interventions. BrightHeart's AI software offers a solution by helping clinicians detect morphological abnormalities suggestive of CHDs, especially in resource-limited settings.
"Fetal heart assessments are among the most technically demanding aspects of prenatal ultrasound," said Cécile Dupont, BrightHeart CEO and a Partner at Sofinnova Partners' 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."
Streamlining Workflow and Improving Accuracy
BrightHeart’s technology is designed to integrate into existing workflows, alleviating the burden on sonographers and OB/GYNs. By automating key aspects of the evaluation process, the software can save time and improve accuracy in practices facing resource constraints.
Rapid Development and Future Growth
Founded just two years ago by pediatric cardiologists Dr. Marilyne Levy and Dr. Bertrand Stos, BrightHeart achieved FDA clearance rapidly. "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 preparing for its U.S. commercial launch, focusing on scaling operations and introducing its technology to clinics and hospitals nationwide.
"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."
