BrightHeart Raises €11M To expand FDA-Cleared Prenatal Ultrasound Platform In US And 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 founding investor Sofinnova Partners, alongside prominent clinicians and angel investors, including Professor Laurent Salomon (former President of ISUOG) and serial medtech entrepreneurs Sacha Loiseau and John Gridley.

BrightHeart has developed a software platform that supports the entire prenatal ultrasound exam guiding clinicians through expert-level fetal heart screening, full anatomical tracking and efficient evaluations. Its FDA-cleared devices integrate seamlessly into routine workflows, enhancing exam completeness, saving time and enabling confident clinical decision-making without disrupting practice.

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Clinically validated, BrightHeart’s technology improves congenital heart defect (CHD) detection rates to over 96%, reduces diagnostic errors, and increases efficiency. The new funding will support U.S. commercialisation, European expansion and ongoing product innovation, scaling the B-Right platform to set a new global standard in prenatal ultrasound.

The company has secured five FDA clearances, partnerships with leading academic centres, and two peer-reviewed publications in Obstetrics & Gynaecology, making it the only provider in the field with published clinical evidence. With its differentiated platform, strong regulatory foundation and proven impact on care delivery, BrightHeart is positioned to scale globally and redefine prenatal imaging standards.

“This new round of funding empowers us to accelerate BrightHeart’s mission of making AI the new standard of care in prenatal ultrasound. Our goal is to enhance diagnostic accuracy, improve outcomes for families and babies and streamline clinical workflows for healthcare professionals. We are thrilled to have the support of our investors, who bring not only deep expertise in healthcare innovation but also proven experience in scaling companies globally,” said Cécile Dupont CEO of BrightHeart and Partner at Sofinnova Partners.

"We are excited to work with our new partners as we enter the next stage of our company's evolution.”

BrightHeart’s Series A co-lead investors, Odyssée Venture and GO Capital, bring extensive experience in supporting the international growth of regulated healthcare technologies.

“BrightHeart has built a defensible clinical foundation in one of the most complex areas of prenatal imaging,” said Julien ANDRIEUX, partner at Odyssée Venture.

“By pairing expert-level screening with tangible workflow benefits and seamless integration, the company is well positioned to become a reference platform in prenatal ultrasound,” added Leïla NICOLAS, partner at GO CAPITAL.

The involvement of the Mussallem CHD Alliance, a flagship initiative of the Linda and Mike Mussallem Foundation supporting individuals born with congenital heart defects highlights BrightHeart’s leading role in improving outcomes for CHD patients and their families worldwide.

“At the Mussallem CHD Alliance, we envision a future where babies born with congenital heart defects have access to early and accurate diagnosis, and BrightHeart’s platform gives us confidence that this future is within reach,” said Orin Herskowitz, President of the Mussallem CHD Alliance.

"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.

Expanding access to innovations like this has the power to dramatically improve the diagnostic landscape for CHD patients and their families addressing a critical urgent need.”