BrightHeart, a global leader in artificial intelligence (AI) solutions for obstetrics and pediatric cardiology, recently presented two groundbreaking studies at the Society for Maternal-Fetal Medicine (SMFM) 2025 Pregnancy Meeting, which took place in Aurora, Colorado, on January 30th. These presentations, featured during both the oral plenary and concurrent sessions, marked the first major unveiling of BrightHeart‘s innovative AI technology and its key clinical findings. The studies sparked considerable enthusiasm, revealing BrightHeart’s tremendous potential to transform prenatal care and improve maternal and fetal health outcomes.
The unveiling of the BrightHeart technology at SMFM 2025 generated excitement within the medical community, particularly for its application in prenatal ultrasound and the screening of congenital heart defects (CHDs). CHDs represent the most common form of birth defect, affecting approximately 1 in 100 babies born each year. Yet, despite advances in imaging technologies, routine prenatal ultrasounds often fail to detect these defects, with up to 70% of cases remaining undiagnosed. The complexity and subtlety of detecting CHDs in fetal heart ultrasounds pose significant challenges, which BrightHeart’s AI technology is poised to address.
“We’ve already seen a positive impact from the use of it’s AI software in our center,” said one attending physician. “As AI continues to revolutionize ultrasound care, BrightHeart’s findings underscore the software’s potential to optimize fetal heart evaluation, streamline workflows, and ultimately enhance the quality of prenatal diagnostics.”
BrightHeart’s AI technology was specifically designed to address this unmet clinical need by significantly improving the accuracy and efficiency of screening for CHDs. With its ability to detect early signs of these defects, the software enhances clinical decision-making and ensures that high-risk pregnancies are appropriately managed. The studies presented at SMFM 2025 further cement the technology’s potential to revolutionize care in the obstetric field.
Study 1: Enhancing Detection Rates for CHDs in Prenatal Ultrasounds
The first study, titled “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. These exams were reviewed by 14 physicians from the US and Europe, including obstetricians (OBGYNs) and maternal-fetal medicine specialists (MFMs) with varying levels of experience. The results revealed that BrightHeart’s AI software significantly improved detection rates for major congenital heart defects, with a 15.3% increase in sensitivity compared to traditional methods. Furthermore, the software also improved efficiency, reducing reading time by 18% for both OBGYNs and MFMs.
This study highlighted the potential of BrightHeart’s AI software to improve both the quality and efficiency of fetal heart ultrasounds. Its most significant impact was seen in low-risk pregnancies, where non-specialist clinicians are typically responsible for interpreting prenatal ultrasounds. By enhancing diagnostic accuracy and reducing the time required to analyze images, BrightHeart’s AI enables healthcare providers to deliver more effective care, particularly in settings where specialized maternal-fetal care may not be readily available.
Study 2: AI’s Accuracy in Detecting CHD-Related Ultrasound Findings
The second study, titled “Artificial Intelligence System Accurately Detects Fetal Ultrasound Findings Suspicious for Major Congenital Heart Defects,” analyzed a total of 877 prenatal ultrasound exams conducted across 11 centers in multiple countries. The results were striking, as BrightHeart’s AI system was able to generate conclusions for 98.8% of the exams, demonstrating impressive accuracy in detecting signs of severe CHD.
BrightHeart’s AI achieved a sensitivity of 98.7% in identifying exams with findings associated with severe CHD, and a specificity of 97.7% in confirming the absence of such findings. These results underscore the transformative potential of BrightHeart’s AI software to significantly enhance early screening for CHD and, ultimately, improve clinical outcomes for both mothers and babies. The ability of BrightHeart’s AI to detect CHD early in pregnancy can facilitate earlier interventions, improving the prognosis for infants born with these defects.
BrightHeart’s CEO, Cécile Dupont, Partner at Sofinnova Partners, expressed the profound impact these findings could have on the field of maternal-fetal care: “The results presented at SMFM 2025 showcase BrightHeart’s dedication to driving innovation in the field. This technology has the ability to change clinical practice by making expert-level diagnostics accessible, regardless of geographic location or specialist availability.”
Clinical Implications and Future of Maternal-Fetal Care
Dr. Jennifer Lam-Rachlin, lead author of the second study and Assistant Professor of Maternal Fetal Medicine at the Icahn School of Medicine at Mount Sinai Hospital, emphasized the clinical implications of the research: “Our early exposure to the BrightHeart AI software has already had a positive impact at our center. As AI continues to transform ultrasound care, BrightHeart’s findings illustrate its ability to optimize fetal heart evaluation, streamline workflows, and ultimately improve prenatal diagnostics.”
Dr. Lam-Rachlin’s perspective highlights an important aspect of BrightHeart’s technology: its potential to democratize access to high-quality prenatal care. In many parts of the world, access to specialized maternal-fetal care can be limited due to geographic, financial, or resource-related constraints. By equipping general practitioners and less experienced clinicians with powerful AI tools, BrightHeart can help bridge these gaps, providing expert-level diagnostic capabilities even in remote or underserved areas.
The recent FDA clearance granted to BrightHeart’s AI technology further underscores its significance in reshaping maternal-fetal health. With regulatory approval now in place, the technology is one step closer to widespread clinical adoption. BrightHeart is inviting collaboration from clinicians, researchers, and industry leaders to continue advancing the capabilities of its AI platform and expand its impact on maternal-fetal health worldwide.
The potential of AI to enhance prenatal care is immense. By improving diagnostic accuracy, streamlining workflows, and enabling earlier detection of fetal heart defects, BrightHeart’s AI technology represents a pivotal advancement in the field of obstetrics. As BrightHeart continues to evolve and refine its platform, the future of prenatal care looks brighter, with AI playing an increasingly central role in delivering better health outcomes for both mothers and their babies.
A Call to Action
As BrightHeart moves forward with its mission to revolutionize maternal-fetal health, it invites healthcare providers and researchers to join in advancing this important work. Together, we can drive meaningful change in prenatal care, ensuring that every mother and child has access to the highest standards of care, no matter where they are located.
BrightHeart’s innovative AI software represents not just a technological breakthrough, but a new approach to maternal-fetal health, one that leverages the power of AI to improve patient outcomes and transform clinical practice. The work presented at SMFM 2025 is just the beginning of an exciting new chapter in the future of prenatal care.
