FDA clears BrightHeart’s AI ultrasound tool

AuntMinnie.com staff writers
May 14, 2025

Obstetrics and pediatric cardiology AI firm BrightHeart has secured clearance from the U.S. Food and Drug Administration (FDA) for its B-Right Views tool.

B-Right Views 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, the company said.

The action follows initial clearance the company received in November 2024 for its 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, BrightHeart noted.

 

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