PARIS — BrightHeart, a global leader in AI-powered solutions for obstetrics and pediatric cardiology, has received its third 510(k) clearance from the U.S. Food and Drug Administration (FDA), solidifying its position as the first company to offer a fully integrated platform for real-time fetal heart documentation and congenital heart defect (CHD) detection. The newly cleared tool, B-Right Views, enhances prenatal care by automatically identifying standard ultrasound views required during second and third-trimester fetal heart evaluations.
This latest regulatory milestone expands the company’s growing suite of AI tools designed to support comprehensive and accurate fetal heart assessments. B-Right Views confirms when all clinically recommended views have been captured during routine anatomy scans, helping ensure exam completeness and consistency across different sonographer experience levels.
The announcement follows two earlier FDA clearances. In November 2024, BrightHeart received its first 510(k) for B-Right Screen, a tool designed to flag structural markers suggestive of CHDs during second-trimester ultrasounds. Earlier this month, a second clearance enabled cart-side access to the AI feedback system, further integrating the platform into clinical workflows.
With the addition of B-Right Views, BrightHeart now delivers a unified solution that offers real-time feedback on both exam completeness and potential structural abnormalities, addressing one of the most complex and error-prone areas in obstetric ultrasound imaging. This advancement marks a significant step toward improving early detection and reducing the need for repeat scans, potentially accelerating triage for high-risk pregnancies.
BrightHeart also received approval for its Predetermined Change Control Plan (PCCP), becoming one of the first companies to gain FDA authorization for pre-approved AI updates. This allows the company to implement algorithm improvements without submitting new FDA applications for each change, paving the way for faster innovation and clinical impact across diverse care settings.
“This milestone reflects the exceptional execution of our team and our leadership in AI-enabled ultrasound care,” said Mike Butchko, Chairman of the Board at BrightHeart. “With multiple FDA clearances in rapid succession, we’re positioned to transform how prenatal imaging is delivered around the world.”
Dr. Nathan Fox, Clinical Professor at the Icahn School of Medicine at Mount Sinai and co-author of The Unexpected, emphasized the clinical impact of BrightHeart’s technology. “By offering real-time alerts during exams, BrightHeart helps sonographers identify missing views on the spot, reducing repeat scans and improving workflow efficiency while potentially catching critical cardiac issues earlier,” he said.
Following the successful pilot program, BrightHeart is now preparing for a limited market release of its integrated platform, aimed at bringing the technology to a select group of clinics. The company is inviting clinicians, researchers, and industry partners to collaborate in advancing maternal-fetal health through AI-powered innovation.
