www.fdanews.com/articles/198278-caption-healths-ai-software-cleared
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Caption Health’s AI Software Cleared
July 30, 2020
The FDA granted Caption Health 510(k) clearance for its artificial intelligence-based software that automatically selects the best clips from ultrasound exams for measuring cardiac ejection fraction — the amount of blood the heart’s left ventricle pumps out during each contraction.
The Caption Interpretation AI software analyzes every pixel and frame in a clip to provide highly accurate measurements, the company said.
The software can be used in point-of-care settings to provide “comparable performance to an expert quantitative measurement,” the company said.