BrightHeart has received US Food and Drug (FDA) 510(k) clearance for its first artificial intelligence (AI) software, designed to transform prenatal ultrasound evaluations of the foetal heart.
Foetal heart ultrasounds exams are essential for detecting congenital heart defects (CHDs), which are the most common type of birth defect, affecting nearly one 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 a solution to these challenges, enabling clinicians to improve the detection of morphological abnormalities suggestive of CHDs, in resource-constrained practices.
“Foetal 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 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 to improve accuracy, in increasingly resource-constrained practices.
The company was founded two years ago, stemming from an idea by paediatric cardiologists Marilyne Levy and Bertrand Stos (both Necker-Sick Children’s Hospital, Paris, France). “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,” said Dupont .
“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.”
