BrightHeart secures €11M Series A to scale AI-guided fetal heart screening
BrightHeart, a European healthtech company building real-time AI assistance for prenatal ultrasound, has raised €11 million in Series A funding to accelerate its expansion in the United States and deepen its footprint across Europe. The round was co-led by Odyssée Venture and GO Capital, with participation from the Mussallem CHD Alliance, Lift Value, IDAHO HealthTech Club via Side Angels, and Sofinnova Partners, the company’s founding investor.
A group of clinicians and medtech entrepreneurs also joined the round, including Prof. Laurent Salomon, Sacha Loiseau, and John Gridley. The company said the new capital will be used to build commercial operations in the US, broaden European deployments, and further refine its AI models for prenatal imaging.
Why fetal heart defects are still hard to catch
Detecting congenital heart defects (CHD) before birth remains one of the most difficult problems in routine prenatal care. Ultrasound is the standard screening tool, but the quality of an exam can vary significantly depending on the operator’s experience, technique, and ability to consistently capture the right cardiac views. Even highly trained clinicians can miss subtle abnormalities when image acquisition is incomplete or when fetal positioning makes the heart difficult to assess.
BrightHeart is betting that software—embedded into the exam itself—can reduce that variability. Its product, the B-Right AI Platform, is designed to integrate directly into standard ultrasound systems and assist clinicians in real time during fetal heart exams. The company says the platform guides sonographers through complex anatomy, improves image completeness, and increases diagnostic confidence without requiring clinicians to change their workflow.
Inside the B-Right AI Platform
At the core of BrightHeart’s approach is real-time guidance intended to make expert-level scanning more reproducible. The software combines several AI capabilities: anatomical tracking, intelligent view recognition, and automated quality checks. In practice, the system aims to ensure that key cardiac views are captured and that no critical steps are missed during an exam.
In clinical settings, that kind of “in-the-moment” support could be particularly valuable for busy maternity units where time constraints and varying levels of ultrasound expertise can impact consistency. The company positions its technology as a way to standardise screening quality across sites, not merely as a second reader after the scan is completed.
Clinical validation and regulatory momentum
BrightHeart is entering this funding phase after a year of regulatory and clinical progress. The company said it received five FDA clearances in 2025 and has formed new partnerships with major academic centres. It also cited two peer-reviewed studies supporting its approach.
According to the company, clinical trials have shown its platform can detect congenital heart defects with over 96% accuracy—a performance level that, if replicated broadly, could significantly raise the bar for routine prenatal screening. As with any medical AI claim, real-world performance at scale will be closely watched, particularly across diverse patient populations, equipment configurations, and operator experience levels.
Cécile Dupont: making AI a trusted clinical ally
Cécile Dupont, CEO and co-founder of BrightHeart—and also a partner at Sofinnova Partners—said the company began with a simple observation: ultrasound quality often depends as much on who is holding the probe as on the equipment or protocol.
“Our goal is to enhance diagnostic accuracy, improve outcomes for families and babies, and streamline clinical workflows for healthcare professionals,” Dupont said in comments accompanying the announcement.
That emphasis on workflow integration is central to the company’s pitch. Hospitals are often reluctant to adopt tools that add friction, require extensive retraining, or demand new hardware. BrightHeart says its system is designed for plug-and-play integration so clinicians can use it on existing ultrasound systems without changing how they conduct exams.
Competition and differentiation in AI ultrasound
The market for AI-assisted ultrasound is increasingly crowded, with large incumbents and specialised startups alike pursuing clinical decision support. BrightHeart operates in a landscape that includes players such as GE HealthCare, Caption Health, and Sonio.
Where BrightHeart aims to stand apart is in its focus on complex organ imaging—particularly the fetal heart—and its emphasis on scientific and regulatory validation. Fetal cardiac screening is a high-stakes use case: false negatives can delay care planning, while false positives can create anxiety and lead to unnecessary follow-up testing. Any AI tool deployed in this setting must earn trust from clinicians, regulators, and patients.
What the funding will support next
With the Series A secured, BrightHeart said it will ramp up commercial operations in the US while expanding across Europe. The company also plans to broaden its research pipeline beyond the heart to cover additional fetal organs and earlier-stage anomaly detection.
Orin Herskowitz, President of the Mussallem CHD Alliance, framed the investment around access and standardisation. “By embedding advanced AI directly into ultrasound workflows, BrightHeart is paving the way for expert-level fetal heart screening to become part of routine prenatal care,” he said, adding that wider access to such tools could “dramatically improve the diagnostic landscape for CHD patients and their families.”
What to watch
The next milestones will likely include evidence of adoption in US health systems, additional peer-reviewed outcomes data, and expansion of the platform’s scope beyond cardiac imaging. If BrightHeart can demonstrate consistent performance across sites while keeping integration friction low, its approach could help move prenatal screening toward more uniform, high-quality detection—an outcome with meaningful implications for families, clinicians, and healthcare systems alike.
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