Heartvue.ai and Innolitics Achieve FDA 510(k) Clearance for Heartvue.Proton, an AI-Powered Cardiac MRI Analysis Platform
Heartvue.ai, a cardiac imaging AI company founded by cardiologists, and Innolitics, a medical device software and regulatory consultancy, today announced that the U.S. Food and Drug Administration has granted 510(k) clearance (K260811) for Heartvue.Proton, Heartvue's machine learning–powered software for viewing, post-processing, and quantitative evaluation of cardiovascular magnetic resonance (MR) images. Innolitics guided Heartvue from initial FDA engagement through clearance.
