BrightHeart announced on June 24 that 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 introduce its platform at the Fetal Medicine Foundation World Congress in Vienna, Austria, at the end of June 2026.
Fetal ultrasound is described as one of the most technically demanding imaging examinations in clinical practice. Detection rates for congenital anomalies remain variable across centers, with up to 50% undetected prenatally due to differences in operator experience, available expertise, and workflow consistency.
BrightHeart said it addresses these challenges through two complementary capabilities: live acquisition guidance to support sonographers during scans and advanced morphological evaluation for structured analysis of fetal organs. The company stated that these features aim to reduce procedural variability and improve protocol adherence regardless of operator experience or site resources.
The platform’s performance is supported by two peer-reviewed studies published in Obstetrics & Gynecology. In a validation study involving 877 examinations against an expert cardiologist reference standard (Zelop et al., Obstet. Gynaecol., 2026), BrightHeart reported sensitivity of 98.7% and specificity of 97.7% among conclusive exams for detecting severe defects.
Cécile Dupont, Chief Executive Officer at BrightHeart, said, “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. 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.”
Laurent Salomon, Past ISUOG President and Professor at Necker-Enfants Malades Hospital Paris as well as BrightHeart Clinical Advisor, said, “In routine clinical practice, the quality of prenatal ultrasound screening remains substantially operator-dependent. Standardised, 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 standardisation within the examination workflow itself, in real time, without disrupting the clinical process.”
The first CE Mark follows an €11 million Series A funding round for BrightHeart as well as FDA clearances and launch through GE HealthCare’s Voluson Solution Store.
