BrightHeart Obtains Third FDA Clearance and PCCP Approval, Becoming First to Offer One Integrated Solution for Real-Time Fetal Heart Documentation and CHD Detection

PARIS--(BUSINESS WIRE)-- BrightHeart, a global leader in artificial intelligence (AI) solutions for obstetrics and pediatric cardiology, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its second device, B-Right Views. This AI powered tool automatically detects the standard views required for second and third-trimester fetal heart ultrasound evaluations within routine anatomy scans. The software supports fetal heart exams by confirming when all recommended views are captured and documented, enabling exam completeness and consistency regardless of operator experience.

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