Heartvue.ai’s machine learning–powered software for cardiovascular magnetic resonance image (MRI) evaluation and analysis has secured US Food and Drug Administration (FDA) clearance.

The Tennessee-based company highlighted that while cardiac MRI is the gold standard for assessing cardiac structure and function, manual analysis of a single study can take up to an hour or more, limiting patient access to quantitative cardiac care.

Heartvue.Proton automates measurements across 2D linear dimensions, ventricular volumes and ejection fraction, and blood flow quantification — although a qualified physician still oversees assessments, the company stated.