BrightHeart secures EU regulatory clearance for prenatal screening AI

FRANCE—Parisian medtech company BrightHeart has received a CE mark for its B-Right AI Platform, clearing the way for the commercial launch of its AI-powered prenatal ultrasound technology across the European Union.

The milestone follows the platform’s earlier regulatory clearances in the United States and marks another step in the company’s global expansion.

The B-Right AI Platform is designed to improve the detection of congenital abnormalities during routine prenatal ultrasound examinations, particularly heart defects that often go unnoticed before birth.

According to the company, as many as half of congenital heart abnormalities remain undetected during pregnancy because ultrasound quality can vary significantly depending on the sonographer’s experience, clinical workflow and available expertise.

AI aims to improve prenatal screening

To address these challenges, BrightHeart combines real-time scan guidance with AI-driven analysis of fetal anatomy.

During an examination, the software helps sonographers capture the required ultrasound views while simultaneously assessing the structure of critical fetal organs.

This approach standardises the scanning process, improves protocol adherence and supports more consistent diagnoses across healthcare facilities.

The platform is expected to be particularly valuable for less experienced clinicians, helping them identify congenital abnormalities earlier while reducing repeat scans and easing pressure on overstretched healthcare systems facing workforce shortages.

BrightHeart Chief Executive Officer Cécile Dupont said prenatal ultrasound remains one of the most operator-dependent examinations in medicine, making consistent screening difficult to achieve at scale.

She noted that the company developed the platform to support standardised examinations in real time without disrupting existing clinical workflows, enabling clinicians to make more confident decisions during routine scans.

Clinical studies support strong performance

BrightHeart’s technology is supported by two peer-reviewed studies published in Obstetrics & Gynecology.

Drawing on data collected from 11 academic centres across two countries, researchers evaluated the platform using 877 prenatal examinations against expert cardiologist assessments.

The studies showed that B-Right identified severe fetal abnormalities with a sensitivity of 98.7% and a specificity of 97.7% and successfully generated a diagnostic result in 98.7% of cases examined.

These findings demonstrate the platform’s ability to improve detection rates while delivering consistent, protocol-driven assessments during routine prenatal care.

European launch follows funding and partnerships

The European rollout follows BrightHeart’s recent €11 million (US$12.8 million) Series A financing, which the company is using to accelerate commercial expansion in both Europe and the United States while continuing product development.

Earlier this year, BrightHeart also integrated the B-Right AI Platform into GE HealthCare’s Voluson Solution Store, allowing healthcare providers using Voluson ultrasound systems to access the software directly within their existing imaging workflow.

BrightHeart will officially introduce the platform to European clinicians during the Fetal Medicine Foundation (FMF) World Congress in Vienna, taking place from June 28 to July 2, 2026.

Company representatives and clinical advisors will present the technology and discuss its role in improving prenatal screening across diverse healthcare settings.

Competition in AI-assisted prenatal imaging continues to grow as more developers introduce software that enhances ultrasound interpretation.

French medtech company Diagnoly has launched its Fetoly platform, which uses AI to detect fetal heart and brain abnormalities and is also integrated into GE HealthCare’s Voluson ultrasound systems.

The rapid expansion of AI-enabled imaging reflects broader growth across the healthcare sector.

According to GlobalData, the combined AI market spanning healthcare providers, pharmaceuticals and medical devices reached US$11.9 billion in 2024 and is projected to grow at a compound annual growth rate of approximately 37%, reaching US$57.4 billion by 2029.