BrightHeart, a pioneer in AI-driven prenatal ultrasound evaluation, today announced the publication of its landmark study in Obstetrics & Gynecology, commonly known as the Green Journal. The study, titled “Artificial Intelligence for the Detection of Fetal Ultrasound Findings Concerning for Major Congenital Heart Defects,” confirms BrightHeart’s AI software as a transformative tool in prenatal screening for congenital heart defects (CHDs). The publication marks a major step in validating the strength and clinical value of BrightHeart’s offering.

The multi-center retrospective study analyzed 877 second-trimester ultrasound examinations from 11 leading institutions, including 280 cases of severe CHDs. Using only standard grayscale ultrasound clips, BrightHeart’s AI automatically analyzed each exam for key signs of severe heart defects, without human input, achieving:

• Sensitivity: 98.7% (95% CI: 96.7–99.5)
• Specificity: 97.7% (95% CI: 96.1–98.6)
• Conclusive output: 98.7% of all exams

These results represent a significant improvement compared to the current standard of care, where CHD detection rates remain below 50% in many settings. By reliably identifying signs of life-threatening heart defects that are often missed in routine prenatal screenings, BrightHeart’s AI addresses one of the most persistent diagnostic challenges in prenatal care.

Dr. Marilyne Levy, author, BrightHeart co-founder and pediatric cardiologist at Necker Hospital (Paris, France), noted: “BrightHeart’s AI doesn’t just flag anomalies, it interprets them with the reasoning of a pediatric cardiologist. This supports physicians to efficiently enhance their expertise with every scan, even in settings without immediate access to pediatric cardiology. It’s a game-changer for global maternal-fetal health.”

This study is the result of close collaboration between specialists in pediatric cardiology, obstetrics, data science and biostatistics aimed at rigorously evaluating the clinical performance of BrightHeart’s B-Right-Screen Solution. “This is a fundamental step that scientifically validates the impact of BrightHeart’s AI in a field where many technologies are brought to market without peer-reviewed evidence, ” said Dr Carolyn M. Zelop, first author and MFM specialist at Valley Health System and Clinical Professor of OB/GYN, NYU Grossman School of Medicine.

“We are honored to see our clinical study published in the Green Journal. The results speak for themselves: by identifying findings suspicious for CHD with a 98.7% sensitivity while maintaining a high specificity, our AI offers powerful support in addressing one of prenatal care’s most pressing diagnostic gaps - the timely detection of congenital heart defects. With fewer trained sonographers and growing medical deserts, prenatal care is under pressure - BrightHeart delivers a scalable, high-quality solution. We are currently expanding our AI portfolio to analyze and support the entire prenatal ultrasound exam, bringing greater consistency, efficiency and ultimately, better outcomes for every parent and baby,” said Cécile Dupont, CEO of BrightHeart and Partner at Sofinnova Partners.

BrightHeart’s FDA-cleared AI software integrates seamlessly into existing ultrasound workflows, providing real-time decision support without disrupting clinical routines. Additional clinical evidence will be presented at the ISUOG World Congress later this month, further reinforcing BrightHeart’s leadership in advancing prenatal care through AI.

About BrightHeart

BrightHeart SAS is a Paris-based, privately held, medical device company and part of Sofinnova MD Start, Sofinnova Partners' medical device accelerator. The company’s software uses cutting-edge artificial intelligence to analyze fetal heart ultrasound exams and support clinicians and sonographers with tools to improve fetal heart evaluations.

The company’s innovative AI technology addresses a critical unmet clinical need, targeting the significant challenge of screening for congenital heart defects (CHDs), the most common type of birth defect. Currently, up to 70% of CHDs cases go undetected during routine prenatal ultrasounds due to the complexity of these exams. BrightHeart offers a first of its kind digital screening tool, which applies AI to detect standard views required during the fetal heart ultrasound evaluation and then flag findings on structural markers that may be suggestive of severe CHDs. This first offering supports the company’s broader vision to deliver expert level ultrasound care - regardless of resources, setting, or expertise.

BrightHeart builds on more than a decade of foundational excellence and innovation in fetal cardiology training established by co-founders Dr. Marilyne Levy and Dr. Bertrand Stos, two leading fetal cardiologists based in Paris, France. Learn more at brightheart.ai.

About Sofinnova Partners

Sofinnova Partners is a leading European venture capital firm in life sciences, specializing in healthcare and sustainability. Based in Paris, London and Milan, the firm brings together a team of professionals from all over the world with strong scientific, medical, and business expertise. Sofinnova Partners is a hands-on company builder across the entire value chain of life sciences investments, from seed to later-stage. The firm actively partners with ambitious entrepreneurs as a lead or cornerstone investor to develop transformative innovations that have the potential to positively impact our collective future.

Founded in 1972, Sofinnova Partners is a deeply established venture capital firm in Europe, with 50 years of experience backing over 500 companies and creating market leaders around the globe. Today, Sofinnova Partners has over €4 billion under management. For more information, please visit: www.sofinnovapartners.com.

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