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# BrightHeart AI Review of Heart Ultrasounds Cleared
- URL: https://www.fdaweb.com/brightheart-ai-review-of-heart-ultrasounds-cleared/
- Published: 2024-11-18T12:00:00.000Z
- Updated: 2026-09-14T14:47:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158206

FDA has cleared a BrightHeart 510(k) for its artificial intelligence (AI) software for reviewing prenatal ultrasound evaluations of the fetal heart. The AI software is designed to “improve the detection of morphological abnormalities suggestive of congenital heart defects (CHDs) in resource-constrained practices,” the company says. “Our AI-powered solution not only assists clinicians in detecting signs of potential abnormalities earlier but also enhances their confidence in confirming normal findings, which is equally critical for the peace of mind of expectant families.”