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# BrightHeart AI Fetal Heart Ultrasound Checker Cleared
- URL: https://www.fdaweb.com/brightheart-ai-fetal-heart-ultrasound-checker-cleared/
- Published: 2025-05-14T12:00:00.000Z
- Updated: 2026-09-14T15:11:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159183

FDA has cleared a BrightHeart 510(k) for the 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,” the company says.

The action follows initial clearance the company received 11/2024 for its 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, BrightHeart noted.

The company says its AI platform performs automatic video stream analysis and processing using AI algorithms. It also performs a live AI assessment of exam completeness during the ultrasound capture, and provides a detailed AI evaluation of fetal heart structures, highlighting abnormal findings or confirming their absence.