BrightHeart Announces CE Mark and European Launch of its AI Platform for Prenatal Ultrasound
BrightHeart, a global leader in AI-driven prenatal ultrasound, today announced it has received the CE mark for its flagship medical devices, enabling commercialization of the B-Right AI Platform across the European Union. The company will make its European debut at the Fetal Medicine Foundation (FMF) World Congress in Vienna, Austria, at the end of June 2026.
Fetal ultrasound is among the most technically demanding imaging examinations in clinical practice, requiring the systematic evaluation of dozens of structures within a limited time window and under highly variable conditions. Despite significant progress in prenatal medicine, detection rates for congenital anomalies remain highly variable across centers with up to 50% remaining undetected prenatally — driven by differences in operator experience, available expertise, and workflow consistency.
BrightHeart addresses this directly through two complementary capabilities. Live acquisition guidance supports sonographers at each step of the scan, reducing procedural variability and improving protocol adherence. Advanced morphological evaluation of critical fetal organs then delivers structured, expert-level analysis that mirrors the diagnostic reasoning of a senior clinician; regardless of operator experience or site resources.
