Heartvue.ai’s machine learning–powered software for cardiovascular magnetic resonance image (MRI) evaluation and analysis has secured US Food and Drug Administration (FDA) clearance.
The Tennessee-based company highlighted that while cardiac MRI is the gold standard for assessing cardiac structure and function, manual analysis of a single study can take up to an hour or more, limiting patient access to quantitative cardiac care.
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Heartvue.Proton automates measurements across 2D linear dimensions, ventricular volumes and ejection fraction, and blood flow quantification — although a qualified physician still oversees assessments, the company stated.
Proton has also been designed to integrate directly with hospital PACS and electronic healthcare record (EHR) systems and into existing cardiology and radiology reading workflows.
Heartvue also highlighted that FDA clearance, which was supported by regulatory consulting firm Innolitics, for the software includes a predetermined change control plan (PCCP), a regulatory tool that allows companies to “pre-clear” certain changes without having to go back to the agency with another 510(k) application.
The inclusion of the PCCP means Heartvue’s machine learning models can improve within pre-specified bounds without requiring a new submission for each update — a factor the company says is important to keep AI performance current as clinical data grows.
Heartvue’s founder and CEO, Jeffrey Dendy, commented: “As a practising 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.”
AI is having a significant impact across healthcare, with a pronounced impact in the medical imaging space. A report by GlobalData forecasts that AI in healthcare will reach a valuation of $57.4bn in 2029. Looking at the FDA’s list of AI-based medical devices approved in 2026, the overwhelming majority are products designed for applications in the medical imaging space.
