BrightHeart has gained a further 510(k) clearance from the US Food and Drug Administration (FDA) for its AI-based prenatal congenital heart defect (CHD) screening platform.
Building on the initial FDA clearance, the French company’s latest clearance adds the ability for clinicians to access BrightHeart’s analysis in real-time through a cart-side tablet.
The company’s AI software, which has been found to improve CHD detection by more than 15%, flags findings on structural markers that may suggest the presence of a CHD in foetal heart ultrasound exams, a provision that the company says resonates with its broader vision to deliver “expert level ultrasound care, regardless of resources, setting, or expertise”.
BrightHeart CEO Cécile Dupont commented: “Our product expansion builds upon the success of our initial pilot experience, bringing real-time feedback directly to the clinicians to streamline the workflow and enhance accuracy.
“Our team rapidly executed from concept to pilot implementation of the BrightHeart tablet in clinics, and we were thrilled to achieve clearance through our first special 510(k) submission within just a few months.”
Following last year’s FDA clearance and with the latest clearance in hand, BrightHeart is gearing up for a limited market release of its platform in a range of US clinics.
According to Dr Jennifer Lam-Rachlin, maternal fetal medicine assistant professor at Icahn School of Medicine at Mount Sinai Hospital/Mount Sinai West Hospital, the experience of using BrightHeart’s tablet during a pilot phase has been “very positive”.
“With real-time alerts on structural markers, BrightHeart supports efficiency in the foetal heart evaluation by bolstering the analysis and documentation for both normal and abnormal scans,” said Lam-Rachlin.
The ability to identify CHDs reflects a high global unmet need, with the defect impacting one in 100 live births worldwide. However, with 70% of cases requiring treatment in the first year of life, more than 90% of cases in low-income and middle-income countries receive no treatment or suboptimal treatment.
According to GlobalData analysis, open heart surgery is the most common approach to correcting CHDs, although minimally invasive techniques have been steadily progressing in recent years.
