June 24, 2026 — BrightHeart 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.
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.
The platform's performance is backed by two peer-reviewed studies published in Obstetrics & Gynecology, conducted with leading academic centers and drawing on data from 11 centers across two countries. In a standalone validation of 877 examinations against an expert cardiologist reference standard (Zelop et al., Obstet. Gynaecol., 2026), the software identified findings associated with severe defects with 98.7% sensitivity and 97.7% specificity among conclusive exams, returning a result in 98.7% of cases, validating BrightHeart's ability to improve detection rates and deliver consistent, protocol-driven evaluations.
BrightHeart's Mission
“Obtaining the CE mark is a critical step in BrightHeart’s mission to make high-quality prenatal screening accessible to every patient, in every center,” shared Cécile Dupont, chief executive officer at BrightHeart. “Fetal ultrasound is one of the most operator-dependent examinations in medicine, leading to significant variability in quality. BrightHeart is built to close that gap, starting with cardiac screening, and extending to brain analysis and support for the full prenatal ultrasound workflow. The FMF World Congress in Vienna is the right stage to introduce this platform to the global fetal medicine community in Europe.”
At the FMF World Congress, BrightHeart’s presence will include key presentations by Pr. Laurent Salomon, past ISUOG president and professor of obstetrics and gynecology at the Necker-Enfants Malades Hospital, Paris, and BrightHeart Clinical Advisor.
Professor Salomon said, “In routine clinical practice, the quality of prenatal ultrasound screening remains substantially operator-dependent. Standardized, protocol-driven examinations have been associated with improved detection of congenital anomalies, yet achieving that level of consistency reproducibly and at scale remains a persistent challenge. BrightHeart is designed to support this standardization within the examination workflow itself, in real time, without disrupting the clinical process.”
March 04, 2026 
