Heartvue.ai gets FDA nod for cardiac MRI analysis software

Heartvue.ai has received U.S. Food and Drug Administration 510(k) clearance for Heartvue.Proton, a machine learning-powered software platform for viewing, postprocessing, and quantitative evaluation of cardiovascular MR images.

The software automates measurements across three domains: 2D linear dimensions, ventricular volumes and ejection fraction, and blood flow quantification. And results are kept under physician review, according to the vendor The software also integrates with hospital PACS and EHR systems and is designed to fit into existing cardiology and radiology reading workflows, Heartvue.ai said.

The clearance includes an FDA-authorized Predetermined Change Control Plan (PCCP), allowing Heartvue.ai to update its machine-earning models within pre-specified bounds without requiring a new 510(k) submission for each update. Heartvue.ai said it will begin commercial rollout to U.S. hospitals and imaging centers.