AI Ultrasound Platform Receives CE Mark for Prenatal Screening

Prenatal ultrasound is central to fetal anomaly screening, yet it remains one of the most technically demanding examinations in routine care. Because both image acquisition and interpretation are highly operator-dependent, inconsistent protocol adherence can allow serious defects to go undetected before birth. These challenges are compounded by time constraints and variable levels of expertise across clinical centers. To address these gaps, a newly launched system provides real-time scan guidance and structured organ-level assessment, following receipt of a CE mark that enables its use across the European Union.

BrightHeart (Paris, France) has received the CE mark for its flagship medical devices, enabling commercialization of the B‑Right AI Platform across the European Union. The company is introducing the system in Europe at the Fetal Medicine Foundation (FMF) World Congress in Vienna taking place from June 28 to July 2, with the platform showcased at stand E1.

B-Right combines two complementary capabilities to strengthen prenatal ultrasound workflows. First, live acquisition guidance supports sonographers step by step, helping reduce procedural variability and improve adherence to standardized protocols. The platform then applies advanced morphological evaluation to critical fetal organs, delivering structured, expert-level analysis that reflects senior-clinician reasoning, regardless of operator experience or site resources.

This performance is supported by two peer-reviewed studies published in Obstetrics & Gynecology, based on data from 11 centers across two countries. In a standalone validation of 877 examinations against an expert cardiologist reference standard (Zelop et al., 2026), the software identified findings associated with severe defects with 98.7% sensitivity and 97.7% specificity among conclusive exams. It returned a result in 98.7% of cases, underscoring the consistency of its protocol-driven evaluations.

Fetal ultrasound requires systematic assessment of numerous structures within limited time and variable conditions, and detection rates for congenital anomalies can vary widely across centers, with up to 50% remaining undetected prenatally. The CE mark follows prior U.S. Food and Drug Administration (FDA) clearances and availability of the B‑Right AI Platform through GE HealthCare’s Voluson Solution Store. The European debut is positioned to support consistent, high‑quality screening across diverse care settings.

“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,” said Cécile Dupont, Chief Executive Officer at BrightHeart.

“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,” stated Laurent Salomon, Past ISUOG (International Society of Ultrasound in Obstetrics and Gynecology) President and Professor of Obstetrics and Gynecology at the Necker-Enfants Malades Hospital, Paris, and BrightHeart Clinical Advisor.

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