BrightHeart, a global leader in artificial intelligence (AI) solutions for obstetrics and pediatric cardiology, presented two groundbreaking studies during the oral plenary and concurrent sessions on January 30th at the Society for Maternal-Fetal Medicine (SMFM) 2025 Pregnancy Meeting, held in Aurora, Colorado. As the first major unveiling of the BrightHeart technology and presentation of key clinical results, these sessions drove significant enthusiasm for BrightHeart’s potential to transform prenatal care.

BrightHeart’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 CHD cases go undetected during routine prenatal ultrasounds due to the complexity of these exams. Formally unveiled in the SMFM 2025 presentation sessions, BrightHeart’s AI software demonstrated the potential to dramatically reduce these missed diagnoses and revolutionize care in the obstetric space.

The first study, “AI Significantly Improves Detection of Prenatal Ultrasounds Suspicious for Major Congenital Heart Defects by OBGYN/MFMs,” was based on a dataset of 200 prenatal ultrasound exams reviewed by 14 US and European physicians with varying levels of experience. The study highlighted how BrightHeart’s AI software significantly improved detection rates with a 15.3% increase in sensitivity, while also improving efficiency with an 18% reduction in reading time among both OBGYNs and MFM specialists. The results highlight the potential of BrightHeart to improve the efficiency and quality of fetal heart ultrasounds, particularly in low-risk pregnancies managed by non-specialists.

The second study, “Artificial Intelligence System Accurately Detects Fetal Ultrasound Findings Suspicious For Major Congenital Heart Defects,” analyzed a total of 877 ultrasound exams from 11 centers across multiple countries. The results demonstrated that BrightHeart’s AI software was able to provide conclusions for 98.8% of exams. Among these, the AI software demonstrated impressive accuracy, identifying exams with signs associated with severe CHD with a sensitivity of 98.7% and confirming the absence of signs associated with severe CHD with a specificity of 97.7%. These results highlight the transformative potential of BrightHeart’s AI technology to significantly enhance early screening of CHD.

BrightHeart CEO and Partner at Sofinnova Partners, Cécile Dupont, expressed the profound impact of these findings, “The results presented at SMFM 2025 underscore BrightHeart’s unwavering commitment to innovation in maternal-fetal care. This technology has the power to transform clinical practice, making expert-level diagnostics accessible to all, regardless of location or specialist availability.”

Dr. Jennifer Lam-Rachlin, lead author and Maternal Fetal Medicine Assistant Professor at Icahn School of Medicine at Mount Sinai Hospital/Mount Sinai West Hospital, Director of Fetal Echocardiography at Carnegie Imaging for Women, emphasized the clinical implications, “Our early exposure to the BrightHeart AI software through these research studies has already had a positive impact on our center. As AI continues to transform ultrasound care, BrightHeart’s findings highlight its ability to optimize fetal heart evaluation, streamline workflows, and improve prenatal diagnostics.”

Recently granted FDA clearance, BrightHeart’s AI technology represents a pivotal step forward in expanding access to expert-level care. BrightHeart invites clinicians, researchers, and industry leaders to collaborate in advancing maternal-fetal health. Together, we can reshape the future of prenatal care.

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.

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.

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 €2.8 billion under management. For more information, please visit: www.sofinnovapartners.com.

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