BrightHeart to Present Groundbreaking AI-Driven Research at the Society for Maternal-Fetal Medicine (SMFM) 2025 Pregnancy Meeting

PARIS--(BUSINESS WIRE)--BrightHeart, a leading AI innovator in obstetric and pediatric cardiology technology, announced today that the groundbreaking results of two key studies of the company’s Artificial Intelligence (AI) software will be presented at the Society for Maternal-Fetal Medicine 2025 Pregnancy Meeting taking place January 27th-February 1st in Aurora, Colorado. These impactful studies underscore the potential of BrightHeart’s AI software to revolutionize the detection of major congenital heart defects during routine second trimester fetal anatomy scans.

Congenital heart defects (CHDs) are among the most common birth defects, affecting approximately 1% of live births. Despite the prevalence and severity of these conditions, current prenatal detection rates remain suboptimal, with 7 out of 10 cases going undiagnosed during pregnancy. This diagnostic gap can lead to delayed care, suboptimal outcomes, and increased risks for both mother and baby. BrightHeart’s mission is to bridge this gap by equipping clinicians with advanced AI tools that enable earlier and more accurate defect identification.

The studies, conducted in collaboration with leading academic institutions and clinical experts, will be presented during two high profile sessions. They represent two of only 104 oral abstracts selected from a field of more than 2,000 submissions.

Session 1: Oral Plenary Session I

• Title: “AI Significantly Improves Detection of Prenatal Ultrasounds Suspicious for Major Congenital Heart Defects by OBGYN/MFMs”
• Date: Thursday, January 30, 2025
• Time: 8:45 AM – 9:00 AM MST
• Presenter: Dr. Jennifer Lam-Rachlin, MD – 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

Session 2: Oral Concurrent Session 3 – Ultrasound and Genetics

• Title: “Artificial Intelligence System Accurately Detects Fetal Ultrasound Findings Suspicious for Major Congenital Heart Defects”
• Date: Thursday, January 30, 2025
• Time: 1:45 PM – 2:00 PM MST
• Presenter: Dr. Carolyn M. Zelop, MD – Valley Health System, Clinical Professor of OB/GYN, NYU School of Medicine

"We are proud to share our groundbreaking clinical results at the SMFM 2025 Pregnancy Meeting, the premier event in maternal-fetal medicine,” said Cécile Dupont, CEO of BrightHeart and a Partner at Sofinnova Partners. "Our findings demonstrate how BrightHeart’s AI can redefine prenatal detection of congenital heart defects. Being selected for the plenary session is a testament to the profound impact of our work and the strength of our clinical collaborations."

Dr. Jennifer Lam-Rachlin, MD, emphasized the importance of innovation in prenatal care, stating, “AI-driven solutions like BrightHeart’s have the ability to change the clinical landscape on the prenatal diagnosis of congenital heart defects by giving clinicians a much-needed tool to significantly improve patient outcomes.”

Adding to this, Dr. Carolyn M. Zelop, MD, noted, “BrightHeart’s technology has the potential to empower practitioners by supporting timely diagnosis, allowing for better-informed care decisions and enhanced outcomes for families.”

These presentations come on the heels of BrightHeart’s recent achievements, including the FDA 510(k) clearance of its first AI software for fetal heart ultrasound evaluations. Based on the outcomes that will be highlighted at the SMFM 2025 Pregnancy Meeting, BrightHeart is poised to offer clinicians transformative tools to support more efficient workflows, earlier diagnosis and comprehensive care planning.

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 with the prenatal identification of congenital heart defects. The technology aims to improve pregnancy outcomes by anticipating delivery care and early intervention.

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.