BrightHeart, a US-based obstetrics and paediatric cardiology solutions provider, has secured a second US Food and Drug Administration (FDA) 510(k) clearance for its platform.
The approval expands the platform’s capabilities, enabling clinicians to access real-time analysis via a cart-side tablet, enhancing foetal heart ultrasound evaluations.
The BrightHeart platform addresses a critical need in prenatal care, focusing on the challenge of screening for congenital heart defects (CHDs), the most prevalent birth defect.
BrightHeart’s AI-driven digital screening tool flags structural markers indicative of CHDs, supporting expert-level ultrasound care regardless of resources or expertise.
The company is planning for a limited market release of its platform in select clinics.
BrightHeart CEO and partner at Sofinnova Partners Cécile Dupont said: “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.”
Based in Paris, France BrightHeart is a privately held medical device company under Sofinnova MD Start, Sofinnova Partners’ medical device accelerator.
The company’s software leverages AI to enhance foetal heart ultrasound exams, aiding clinicians and sonographers in improving evaluations.
Sofinnova Partners, a European venture capital firm investing in life sciences, is headquartered in Paris, London, and Milan.
Established in 1972, Sofinnova Partners manages over €4bn and has backed more than 500 companies globally, creating market leaders in the process.
Icahn School of Medicine at Mount Sinai Hospital/Mount Sinai West Hospital maternal fetal medicine assistant professor Jennifer Lam-Rachlin said: “The clinician reception to the BrightHeart tablet has been very positive during our pilot experience.
“With real-time alerts on structural markers, BrightHeart supports efficiency in the fetal heart evaluation by bolstering the analysis and documentation for both normal and abnormal scans – ultimately boosting confidence and consistency in the exam room.”
Michigan Perinatal Associates founding partner and perinatologist Sara Garmel said: “Heart defects are so hard to detect, and so devastating if missed.
“By surfacing the alerts directly during the scan, BrightHeart helps bring greater structure and efficiency to fetal heart exams to support earlier and more accurate detection.”
