Nashville-based Heartvue.ai and medical-device engineering partner Innolitics announced FDA 510(k) clearance on September 3, 2026 for Heartvue.Proton, an AI-enabled platform that reads, processes and evaluates cardiac magnetic resonance imaging.
What the platform does
Heartvue.Proton automates 2D linear dimensions, ventricular volumes and ejection fraction, and blood flow quantification for cardiac MRI, then surfaces the measurements for physician review. It is designed to slot into an existing PACS or EHR-linked cardiology or radiology workflow.
Regulatory design that keeps up with the model
The clearance includes an FDA-authorised Predetermined Change Control Plan, letting Heartvue update its machine-learning models within pre-specified bounds without a new submission for each iteration - a pattern seen in other recent AI-imaging authorisations such as Elucid's cardiovascular AI.
Founded by cardiologists
Heartvue.ai was founded by practising cardiologists and is a member of the NVIDIA Inception program. The Proton clearance places the company in a fast-growing FDA AI-imaging cohort, which continues to dominate clinical AI approvals.
Reporting based on coverage from Medical Device Network, PharmaShots, Cardiovascular Business and Heartvue.ai.