BrightHeart has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its second device, B-Right Views.

The artificial intelligence (AI)-powered tool automatically spots the standard views needed for second and third-trimester fetal heart ultrasound evaluations in routine anatomy scans. The software supports fetal heart exams by confirming when all recommended views are captures and documented.

With this latest FDA nod, the company became one of the first to gain approval for its Predetermined Change Control Plan (PCCP). The plan lets BrightHeart implement preauthorized, separate FDA submissions.

The company recently achieved several regulatory milestones to reinforces its AI-powered prenatal care portfolio. November 2024 saw FDA clearance for the BrightHeart’s B-Right Screen AI software, which flags structural markets suggestive of congenital heart defects (CHDs) to assist in their detection during second-trimester fetal ultrasounds.

Earlier this month, the company also gained FDA clearance for a platform expansion so clinicians can access the B-Right Screen AI feedback via a cart-side tablet.

The latest clearance makes BrightHeart the first, only company with an integrated solution to offer real-time, comprehensive feedback on fetal heart documentation while simultaneously flagging a comprehensive set of structural markers that could be suggestive of severe CHDs.

“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’s Board Chairman. “This milestone also reflects the exceptional execution of the team, delivering multiple clearances in record time.”