BrightHeart Earns CE Mark for AI Platform for Prenatal Ultrasound

BrightHeart, a company focused on AI-driven prenatal ultrasound, has earned a CE mark for its flagship devices, allowing commercialization of the B-Right AI platform across the EU.

The company aims to address the technically demanding imaging examinations in fetal ultrasound. Its live acquisition guidance supports sonographers at each step of the scan to reduce procedural variability and improve adherence to protocol.

Advanced morphological evaluation of critical fetal organs then provides structured, expert-level analysis that mirrors the diagnostic reasoning of a senior clinician, regardless of operator experience or site resources.

The platform was backed by two peer-reviewed studies published in Obstetrics & Gynecology, conducted with leading academic centers and drawing data from 11 centers in two countries. In a standalone validation of 877 examinations against an expert cardiologist reference standard, the software identified findings associated with severe defects with 98.7% sensitivity and 97.7% specificity, delivering conclusive results in 98.7% of cases and demonstrating its ability to improve detection rates through consistent, protocol-driven evaluations.

The first CE mark for BrightHeart’s devices follows a €11 million Series A funding, their U.S. Food and Drug Administration (FDA) clearances, and release of the B-Right AI platform through GE HealthCare’s Voluson Solution Store.

Comments from BrightHeart and clinicians

Cécile Dupont, CEO, BrightHeart: “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.”

Pr. Laurent Salomon, past ISUOG president and Professor of Obstetrics and Gynecology at the Necker-Enfants Malades Hospital, Paris, and BrightHeart clinical advisor: “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.”