Medtech innovator BrightHeart, a specialist in artificial intelligence solutions for prenatal ultrasound, has announced the closing of an €11 million Series A financing round to accelerate global adoption of its AI-powered platform for fetal heart screening. The round was co-led by Odyssée Venture and GO Capital, with additional participation from the Mussallem CHD Alliance, Lift Value, IDAHO HealthTech Club via Side Angels, founding investor Sofinnova Partners, and several prominent clinicians and angel investors.
The financing will support US commercialisation, expansion across Europe, and continued development of BrightHeart’s B-Right AI Platform, an integrated software suite designed to guide clinicians through complex prenatal ultrasound exams. The company aims to establish a new global standard of care by embedding AI-driven expert support directly into routine imaging workflows, enhancing consistency, accuracy, and exam completeness.
Addressing a Critical Gap in Prenatal Care
Congenital heart defects, CHDs, remain the most common type of birth defect worldwide. While early and accurate detection is essential for preparing families and clinicians for appropriate interventions after birth, many CHDs go undiagnosed during routine prenatal imaging due to the complexity of fetal cardiac assessment and variations in sonographer experience. This creates a critical need for tools that can deliver real-time expertise at the point of care.
BrightHeart’s platform addresses this need by providing continuous, step-by-step guidance during ultrasound exams. The software recognises standard fetal heart views, evaluates anatomical structures, checks exam completeness, and supports clinicians in capturing the right images at the right moments. Designed to work seamlessly within existing workflows, the system helps boost confidence, reduce errors, and standardise exam quality across providers.
Clinical validation has shown that BrightHeart’s technology can dramatically improve CHD detection rates to above 96 per cent while reducing diagnostic variability and improving efficiency. By supporting clinicians during the full exam rather than at isolated steps, the platform ensures that critical cardiac views are obtained more consistently, leading to earlier and more reliable detection of abnormalities.
Strong Regulatory and Clinical Foundations
BrightHeart has built a robust regulatory foundation, achieving five FDA 510(k) clearances across its AI-enabled tools for prenatal imaging. These clearances reflect the safety, performance, and clinical value of the company’s approach to expert-level ultrasound guidance. The company has also established partnerships with major academic and clinical centres and has secured two peer-reviewed publications in leading medical journals, making it the only player in its field with published clinical evidence supporting its platform.
Independent evaluations in real-world clinical settings have reinforced the platform’s impact, demonstrating improvements in detection accuracy, workflow efficiency, and clinician confidence. These studies highlight the platform’s ability to elevate both the quality and reliability of routine fetal heart screening, even in environments where specialised expertise may not always be available.
Investor Confidence and Vision for the Future
Cécile Dupont, CEO of BrightHeart and Partner at Sofinnova Partners, said the new investment will accelerate the company’s mission to make AI the new standard of care in prenatal ultrasound. She emphasised that the technology is designed to improve diagnostic outcomes for families and babies while streamlining workflows for clinicians.
Odyssée Venture and GO Capital, the round’s co-lead investors, highlighted BrightHeart’s strong clinical evidence and its potential to become a reference platform in prenatal ultrasound. The participation of the Mussallem CHD Alliance, a major initiative dedicated to improving the lives of people born with congenital heart defects, underscores the global significance of increasing early detection and access to advanced screening technologies.
Looking Ahead
With fresh capital, a differentiated platform, and growing demand for AI-driven prenatal imaging, BrightHeart is positioned to scale globally, expand commercial partnerships, and continue advancing its technology. The company plans to broaden clinical deployments, enhance its AI capabilities, and work closely with healthcare institutions to redefine the standard of care in prenatal ultrasound.
