French medical device maker BrightHeart has secured the US Food and Drug Administration (FDA) 510(k) approval for its AI-powered software for prenatal ultrasound analysis.
The software is designed to advance prenatal ultrasound evaluations of the foetal heart.
BrightHeart said the tool can be easily integrated into existing workflows, reducing the burden on overworked sonographers and obstetrician-gynaecologists (OB/GYNs).
It automates the important aspects of the evaluation process, saving time and improving accuracy in practices that are increasingly resource-constrained.
BrightHeart is preparing for the US launch of the software, to scale operations, enter the market and showcase its solution in clinics and hospitals across the country.
BrightHeart CEO and Sofinnova Partners medtech accelerator partner Cécile Dupont said: “Foetal heart assessments are among the most technically demanding aspects of prenatal ultrasound.
“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.
“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.”
According to the French medical device company, foetal heart ultrasound exams play a key role in detecting congenital heart defects (CHDs), the most common birth defects.
However, misdetection or delayed diagnosis can lead to severe consequences, including missed opportunities for life-saving interventions.
Its new AI-powered software provides an advanced solution, enabling clinicians to improve the detection of morphological abnormalities suggestive of CHDs, said BrightHeart.
BrightHeart chairman Michael Butchko said: “Resource constraints and workforce shortages are critical challenges in prenatal care, and we believe BrightHeart is uniquely positioned to address them.
“In this next phase, we aim to deliver our transformative technology to clinicians and expectant families, making a measurable impact on prenatal care outcomes.”
