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.

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. Gynecol., 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.

“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.”

The FMF World Congress is an annual scientific meeting that brings together fetal medicine specialists, obstetricians, and sonographers from around the world. BrightHeart’s presence at the 2026 meeting will include key presentations from 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 highlighted:

“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.”

The first CE Mark of BrightHeart’s medical devices follows a €11M Series A funding, their FDA clearances, and the launch of the B-Right AI Platform through GE HealthCare’s Voluson™ Solution Store. The European launch will take place at the FMF World Congress from June 28 to July 2, at stand E1.

About BrightHeart

BrightHeart is a global leader in artificial intelligence (AI) solutions for prenatal ultrasound, with an AI software platform that delivers support across the entire ultrasound exam, providing guidance at every step for expert-level screening, automated view recognition, precise tracking of the full anatomy, and efficient evaluations. Its FDA-cleared and CE-marked medical devices integrate directly into routine ultrasound workflows to deliver best-in-class critical organ evaluation, improve exam completeness, save time, and support confident clinical decision-making — without disrupting how clinicians work.

BrightHeart’s technology has been clinically validated to dramatically improve CHD detection (>96%) while reducing diagnostic errors and improving efficiency. Built for connected care at scale, BrightHeart provides continuous support from first view to final review — wherever prenatal ultrasound happens. Learn more at https://www.brightheart.ai/.

The B-Right AI Platform is a marketing term encompassing all BrightHeart's "B-Right" solutions. Please check the regulatory information available on the website about each medical device for more details.

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