The tool automatically detects the standard views required for second- and third-trimester fetal heart ultrasound evaluations.
BrightHeart announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its second device, B-Right Views, an artificial intelligence (AI)-powered tool that 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, according to a release from the company.
This marks the third clearance for the company. In November 2024, the company received its initial 510(k) clearance for BrightHeart’s B-Right Screen AI software, which flags structural markers that are suggestive of congenital heart defects to assist in their detection during second-trimester fetal ultrasounds. Earlier this month, the company received its second clearance for platform expansion, enabling clinicians to access the B-Right Screen AI feedback directly via the cart-side tablet.
Real-Time Feedback on Fetal Heart Documentation
With this latest clearance, BrightHeart offers clinicians an integrated solution that is designed to provide real-time feedback on fetal heart documentation while simultaneously flagging a comprehensive set of structural markers that may be suggestive of severe congenital heart defects.
As part of this clearance, BrightHeart achieves approval for its Predetermined Change Control Plan. 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 says in a release that it is poised to deliver product enhancements efficiently.
“BrightHeart’s AI has the potential to offer immediate workflow benefits and measurable clinical value,” says Nathan Fox, MD, 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,” in a release. “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.”
BrightHeart is preparing for a limited market release.
Photo caption: Example output screen the B-Right AI Platform
Photo credit: BrightHeart
