Caption Health’s AI Software Cleared

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.