BrightHeart, a global leader in artificial intelligence (AI) solutions for obstetrics and pediatric cardiology, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its second device, B-Right Views. This AI powered tool automatically detects the standard views required for second and third-trimester fetal heart ultrasound evaluations within routine anatomy scans. The software supports fetal heart exams by confirming when all recommended views are captured and documented, enabling exam completeness and consistency regardless of operator experience.
BrightHeart has recently reached several key regulatory milestones, reinforcing its leadership in AI-powered prenatal care. The company's FDA clearances include:
- November 2024: Initial 510(k) clearance for BrightHeart's B-Right Screen AI software, which flags structural markers that are suggestive of congenital heart defects (CHDs) to assist in their detection during second-trimester fetal ultrasounds.
- May 2025: Second 510(k) clearance for platform expansion, enabling clinicians to access the B-Right Screen AI feedback directly via the cart-side tablet.
- May 2025: Announced today third 510(k) clearance, for its second device, B-Right Views, expanding the platform's clinical applications by identifying and confirming the presence of required views for the fetal heart evaluation
With this latest clearance, BrightHeart becomes the first and only company to offer clinicians an integrated solution that provides real-time, comprehensive feedback on fetal heart documentation while simultaneously flagging a comprehensive set of structural markers that may be suggestive of severe CHDs. This milestone represents a significant breakthrough in one of the most complex and clinically challenging aspects of obstetric ultrasound imaging.
As part of this most recent clearance, BrightHeart has become one of the first companies to achieve approval for its Predetermined Change Control Plan (PCCP). This plan allows BrightHeart to implement pre-authorized future improvements to the AI at the core of the device, without requiring separate FDA submissions. With this upfront alignment in place, BrightHeart is poised to deliver product enhancements efficiently, accelerating clinical impact and enabling rapid iteration to scale clinical value across various care settings.
"As the industry rapidly shifts to one that is AI-enabled, BrightHeart is at the leading edge of innovation and poised to transform how ultrasound care is delivered globally," said Mike Butchko, BrightHeart Board Chairman. "This milestone also reflects the exceptional execution of the team, delivering multiple clearances in record time."
"BrightHeart's AI has the potential to offer immediate workflow benefits and measurable clinical value," said Dr. Nathan Fox, Clinical Professor in the Raquel and Jaime Gilinski Department of Obstetrics, Gynecology, and Reproductive Science at the Icahn School of Medicine at Mount Sinai, Partner at Carnegie Imaging for Women, host of Healthful Woman Podcast, and co-author of "The Unexpected." "By providing real-time alerts, BrightHeart helps sonographers to identify and correct missing views during the exam, reducing the need for repeat scans while potentially boosting sonographer confidence and facilitating earlier triage of high-risk cases."
With three clearances achieved in record time and the PCCP in place, BrightHeart is now preparing for a limited market release, which will build on the success of the early pilot program and introduce BrightHeart to a select group of clinics. BrightHeart invites clinicians, researchers, and industry leaders to join us 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.
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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Contacts:
For further information:
Cécile Dupont
Chief Executive Officer, BrightHeart
press@brightheart.fr
