FDA clears Heartvue’s cardiac image evaluation software

Heartvue.Proton is designed to streamline cardiovascular MRI evaluation. Heartvue.Proton is designed to streamline cardiovascular MRI evaluation. Heartvue’s FDA clearance includes a predetermined change control plan (PCCP), meaning it can improve its machine learning models within pre-specified bounds without requiring a new FDA submission for each update. Credit: sdecoret/Shutterstock.com 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…

Source: Medical Device Network