BrightHeart, a global leader in artificial intelligence (AI) solutions for obstetrics and pediatric cardiology, unveiled groundbreaking studies at the Society for Maternal-Fetal Medicine (SMFM) 2025 Pregnancy Meeting in Aurora, Colorado. These studies demonstrate the transformative potential of BrightHeart’s AI technology in prenatal care.
Addressing Critical Gaps in Prenatal Screening
Congenital heart defects (CHDs) are the most common type of birth defect, yet up to 70% of cases go undetected during routine prenatal ultrasounds due to their complexity. BrightHeart’s innovative AI technology aims to bridge this gap by enhancing detection rates and efficiency in prenatal screenings.
Study Highlights
In the first study, titled “AI Significantly Improves Detection of Prenatal Ultrasounds Suspicious for Major Congenital Heart Defects by OBGYN/MFMs,” a dataset of 200 prenatal ultrasound exams was reviewed by 14 physicians from the U.S. and Europe with varying experience levels. The findings revealed that BrightHeart’s AI software improved detection rates with a 15.3% increase in sensitivity and enhanced efficiency with an 18% reduction in reading time among both OBGYNs and MFM specialists. These results underscore 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 877 ultrasound exams from 11 centers across multiple countries. BrightHeart’s AI software provided conclusions for 98.8% of exams, demonstrating impressive accuracy with a sensitivity of 98.7% in identifying signs associated with severe CHD and a specificity of 97.7% in confirming their absence. These findings highlight the transformative potential of BrightHeart’s AI technology to significantly enhance early screening of CHD.
Expert Endorsements
Cécile Dupont, BrightHeart CEO and Partner at Sofinnova Partners, emphasized the profound impact of these findings, stating, “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, and Director of Fetal Echocardiography at Carnegie Imaging for Women, highlighted the clinical implications, noting that early exposure to the BrightHeart AI software through these research studies has already had a positive impact on their center. She added, “As AI continues to transform ultrasound care, BrightHeart’s findings highlight its ability to optimize fetal heart evaluation, streamline workflows, and improve prenatal diagnostics.”
Regulatory Milestone and Call for Collaboration
Recently granted FDA clearance, BrightHeart’s AI technology represents a pivotal step forward in expanding access to expert-level care. The company invites clinicians, researchers, and industry leaders to collaborate in advancing maternal-fetal health, aiming to 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.
