BrightHeart, a developer of AI-driven prenatal ultrasound technology, has received CE Mark for its B-Right AI platform, enabling direct integration into routine prenatal care across the European Union.
The platform addresses a persistent clinical gap: detection rates for congenital anomalies during prenatal ultrasound remain highly variable, often dependent on operator experience and site resources. BrightHeart’s AI delivers a live assessment of exam completeness during the ultrasound capture and advanced morphological evaluation of critical fetal organs, providing structured, expert-level analysis that mirrors the diagnostic reasoning of a senior clinician – regardless of who is performing the scan.
Clinical validation has shown the platform improves prenatal detection of major congenital heart defects by 96.4%, while reducing false positive errors by 88% and false negative errors by 70%.
The CE Mark adds to BrightHeart’s existing regulatory footprint of five FDA clearances in the U.S. The cloud-based platform connects to existing ultrasound machines without requiring new hardware.
