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Sept. 2, 2026 — Heartvue.ai and Innolitics have announced the U.S. Food and Drug Administration has granted 510(k) clearance 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.
Cardiac MRI is the gold standard for assessing cardiac structure and function, but manual analysis of a single study can take up to an hour or more, limiting patient access to quantitative cardiac care. Heartvue.Proton automates time-consuming measurements across three domains — 2D linear dimensions, ventricular volumes and ejection fraction, and blood flow quantification — while keeping every result under the review and control of a qualified physician. The platform integrates directly with hospital PACS and EHR systems and fits into existing cardiology and radiology reading workflows.
Notably, the clearance includes an FDA-authorized Predetermined Change Control Plan (PCCP). PCCP is a regulatory tool that allows companies to “pre-clear” certain changes without having to go back to the agency with another 510(k). For Heartvue, this means its machine learning models can improve within pre-specified bounds without requiring a new submission for each update — an important capability for keeping AI performance current as clinical data grows.
Innolitics supported Heartvue across the full regulatory lifecycle, including regulatory strategy, FDA Pre-Submission preparation, clinical validation study design, AI/ML and cybersecurity documentation, PCCP development, and management of FDA interactions through review. The 510(k) was cleared approximately five and a half months after submission.
Heartvue.ai will begin commercial rollout of Heartvue.Proton to U.S. hospitals and imaging centers, building on its existing beta site network.
August 05, 2026 
