Parisian medtech company, BrightHeart, has obtained a CE mark for its artificial intelligence (AI)-based tool to optimise the prenatal ultrasound process – marking a commercial expansion for the technology following its prior clearance in the US.
Dubbed the B-Right AI Platform, BrightHeart’s technology is designed to address the variability in the identification of heart defects during prenatal scans, with up to 50% remaining undetected before birth due to differences in workflow, expertise and operator experience between sites, the company claims.
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The B-Right AI Platform achieves this by both standardising the prenatal ultrasound exam process and helping clinicians to accurately interpret the results of the scan. According to BrightHeart, the technology’s ability to evaluate the form and structure of critical foetal organs could potentially help more junior staff to diagnose congenital anomalies early, saving healthcare systems time and potentially relieving pressure on them, as many in Europe contend with staff shortages.
In a statement, BrightHeart’s CEO Cécile Dupont pointed out that the quality of prenatal ultrasound screening is mostly operator-dependent, and that consistency and reproducibility of results at scale remain a “persistent challenge” for healthcare.
“BrightHeart is designed to support this standardisation within the examination workflow itself, in real time, without disrupting the clinical process,” Dupont added.
In two peer-reviewed studies comparing BrightHeart’s solution across 877 examinations against an expert cardiologist reference standard, B-Right identified severe defects with a sensitivity and specificity of 98.7% and 97.7%, respectively, while returning a result in 98.7% of cases.
B-Right’s upcoming European launch comes shortly after BrightHeart secured €11m ($12.8m) in funding to drive the adoption of the AI-powered technology across the US, after the device received its first clearance from the Food and Drug Administration (FDA) in 2024, followed by an additional US regulatory blessing in 2025.
AI’s growing healthcare presence
As BrightHeart gears up to launch its platform at the Fetal Medicine Foundation (FMF) World Congress, which is being held in Vienna from 28 June to 2 July 2026, the company will have to contend with burgeoning competition in the space, as AI tools for medical imaging become increasingly commonplace.
One competitor is a medtech company and fellow compatriot, Diagnoly, which has developed Fetoly, an AI-enabled ultrasound platform that is designed to detect heart and brain defects in utero.
Both BrightHeart and Diagnoly have struck a partnership with prominent medtech player, GE Healthcare, in recent times, which has seen both B-Right and Fetoly become integrated into GE’s Voluson ultrasound systems.
These developments come a little after DeepLook Medical’s CEO, Marissa Fayer, told Medical Device Network that AI’s application in medical imaging has “no endpoint”, but infrastructure is currently lagging.
Currently, GlobalData estimates that, across healthcare providers, pharmaceuticals and medical devices, the combined AI market was worth $11.9bn in 2024, with this value expected to appreciate at a compound annual growth rate (CAGR) of around 37% to $57.4bn in 2029.
