Clearance includes a Predetermined Change Control Plan (PCCP), achieved on the company’s first FDA submission in partnership with Innolitics
BRENTWOOD, Tenn. & AUSTIN, Texas–(BUSINESS WIRE)–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.
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 PCCP. PCCP, or Predetermined Change Control Plan, 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.
“As a practicing cardiologist, I built Heartvue.Proton to give clinicians back the time they spend on manual measurements and to make quantitative cardiac MRI available to every patient who needs it. Clearing FDA on our first submission, with a PCCP included, is a testament to our team and to the Innolitics partners who guided us at every step. They understood both the science and how FDA thinks.”
Jeffrey Dendy, MD, CEO and Founder of Heartvue.ai
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.
About Heartvue.ai
Heartvue.ai is a medical imaging AI company based in Brentwood, Tennessee, founded by Dr. Jeffrey Dendy, a cardiologist and Assistant Professor of Cardiovascular Medicine at Vanderbilt University Medical Center. Heartvue builds AI-powered automation for cardiovascular imaging, beginning with Heartvue.Proton for cardiac MRI. Learn more at heartvue.ai.
About Innolitics
Innolitics is a software development and regulatory consulting firm that helps medical device companies bring innovative products to market. From regulatory strategy and FDA submissions to medical imaging software engineering and cybersecurity, Innolitics has guided dozens of AI/ML medical devices through the FDA. Learn more at innolitics.com.
Contacts
Heartvue.ai: Jeffrey M. Dendy, M.D., CEO, [email protected] | Heartvue.ai
Innolitics: Mekha Thomas, [email protected] | Innolitics.com