BrightHeart, a Paris-based artificial intelligence company specializing in obstetrics and pediatric cardiology, has received its third FDA 510(k) clearance for B-Right Views, an AI-powered device designed to ensure standard fetal heart ultrasound views during second and third-trimester exams.
The newly cleared technology provides automated confirmation when recommended views are obtained and documented during fetal ultrasound exams, enabling consistent assessment quality regardless of a clinician's experience level with ultrasound imaging.
This latest regulatory milestone follows two previous FDA clearances: one for BrightHeart's B-Right Screen AI software for detecting congenital heart defects (CHDs) and another expanded clearance earlier this month allowing access to AI feedback through a cart-side tablet during examinations.
Addressing a Critical Clinical Challenge
Congenital heart defects represent the most common type of birth defect, yet up to 70% go undiagnosed during standard prenatal ultrasounds, according to BrightHeart. The company's AI platform aims to address this significant gap by flagging potential structural abnormalities in the fetal heart during routine examinations.
"Heart defects are so hard to detect, and so devastating if missed," said Sara Garmel, perinatologist and founding partner at Michigan Perinatal Associates. "By surfacing the alerts directly during the scan, BrightHeart helps bring greater structure and efficiency to fetal heart exams to support earlier and more accurate detection."
The technology works by analyzing fetal heart ultrasounds in real-time and providing immediate feedback to clinicians, potentially reducing the need for repeat scans while boosting sonographer confidence and facilitating earlier identification of high-risk cases.
Real-Time Analysis Enhances Clinical Workflow
A key advancement in the latest FDA clearance is the integration of real-time analysis capabilities through a cart-side tablet during fetal ultrasound exams. This feature streamlines the clinical workflow by providing immediate feedback without disrupting the examination process.
"BrightHeart's AI has the potential to offer immediate workflow benefits and measurable clinical value," explained Nathan Fox, M.D., a clinical professor in the Raquel and Jaime Gilinski Department of Obstetrics, Gynecology, and Reproductive Science at the Icahn School of Medicine at Mount Sinai. "By providing real-time alerts, BrightHeart helps sonographers to identify and correct missing views during the exam, reducing the need for repeat scans."
Jennifer Lam-Rachlin, a maternal-fetal medicine specialist at Mount Sinai Hospital in New York, noted that the device helps improve both efficiency and confidence during examinations.
Regulatory Pathway and Future Development
In addition to the three FDA clearances, BrightHeart has received approval for a Predetermined Change Control Plan (PCCP), which allows the company to make pre-authorized improvements to the AI device without requiring separate submissions for FDA clearance. This regulatory pathway could accelerate future enhancements to the technology.
"Our product expansion builds upon the success of our initial pilot experience, bringing real-time feedback directly to the clinicians to streamline the workflow and enhance accuracy," said Cécile Dupont, CEO of BrightHeart and partner at Sofinnova Partners. "We were thrilled to achieve clearance through our first Special 510(k) submission within just a few months."
BrightHeart is part of Sofinnova MD Start, the medical device accelerator from Sofinnova Partners. With its regulatory approvals secured, the company is now preparing for a limited market release to deploy the platform in select clinics, while encouraging collaboration from clinicians, researchers, and industry partners to expand access to AI-supported prenatal care.
AI's Growing Role in Prenatal Care
The adoption of AI in prenatal imaging represents part of a broader trend across medicine, where artificial intelligence is improving diagnostic accuracy, enhancing clinical workflows, and expanding access to expert-level care.
In fields like obstetrics and pediatric cardiology, where early detection of abnormalities can significantly impact outcomes, AI tools provide valuable decision support during exams, offer standardized analysis, and help reduce the cognitive burden of interpreting complex scans.
These capabilities are particularly important in busy or resource-limited settings where access to pediatric cardiology specialists may be limited. By integrating AI directly into the examination workflow, technologies like BrightHeart's platform can help democratize access to high-quality prenatal cardiac assessment.
While challenges around data privacy, regulation, and clinician trust remain, AI is increasingly becoming an essential tool in the movement toward more precise, accessible, and scalable healthcare solutions for maternal and fetal health.
