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BrightHeart's AI-Powered Fetal Heart Ultrasound Software Receives FDA Clearance

• BrightHeart has secured FDA 510(k) clearance for its AI software, designed to aid in prenatal ultrasound evaluations of fetal hearts, enhancing the detection of congenital heart defects. • The AI technology integrates into current clinical workflows, assisting sonographers and OB/GYNs in assessing fetal hearts and improving the accuracy of early abnormality detection. • BrightHeart aims to address resource constraints and workforce shortages in prenatal care by deploying its technology in clinics and hospitals across the United States. • Developed with insights from pediatric cardiologists, the software not only helps detect potential abnormalities but also boosts clinician confidence in confirming normal findings.

BrightHeart has announced that its artificial intelligence (AI) software for prenatal ultrasound evaluations of the fetal heart has received FDA 510(k) clearance. The technology is designed to support the detection of congenital heart defects (CHDs), which affect approximately 1 in 100 newborns.
The AI-powered solution integrates into existing workflows to assist sonographers and OB/GYNs in evaluating fetal hearts. According to Cécile Dupont, BrightHeart CEO, the software assists clinicians in detecting potential abnormalities earlier and enhances their confidence in confirming normal findings. The Paris-based company developed the technology based on work by pediatric cardiologists Dr. Marilyne Levy and Dr. Bertrand Stos.
Michael Butchko, Chairman of BrightHeart, stated that the company is uniquely positioned to address resource constraints and workforce shortages in prenatal care. Following the FDA clearance, BrightHeart plans to launch commercially in the United States, focusing on implementing its solution in clinics and hospitals across the country to make a measurable impact on prenatal care outcomes.
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Reference News

[1]
BrightHeart Receives FDA Clearance for AI-Powered Fetal Heart Ultrasound Software
femtechinsider.com · Nov 18, 2024

BrightHeart receives FDA 510(k) clearance for AI software aiding in prenatal ultrasound evaluations of fetal hearts, aim...

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