AI software designed to transform prenatal ultrasound receives FDA clearance

BrightHeart has announced it has received FDA 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 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 enables 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.

“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 has said it is poised for its U.S. commercial launch, driving efforts to scale operations and enter the market.

“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.”