A single cardiac MRI can take a specialist an hour or more to measure by hand. That bottleneck is what a small Tennessee company says its newly cleared software is built to remove.
Heartvue.ai, based in Brentwood and founded by cardiologists, announced on September 2 that the US Food and Drug Administration has granted 510(k) clearance, number K260811, to Heartvue.Proton. The program uses machine learning to view, process and measure cardiovascular magnetic resonance images. Innolitics, a medical device software and regulatory consultancy in Austin, guided the company from its first FDA contact through to clearance. The review took roughly five and a half months from submission.
What the software measures
Cardiac MRI is considered the gold standard for judging the heart’s structure and function. The catch is the time it takes, which the company says limits how many patients get quantitative results. Heartvue.Proton automates three kinds of measurement: two-dimensional linear dimensions, ventricular volumes and ejection fraction, and blood flow. A qualified physician still reviews and controls every result. The software plugs into hospital PACS and electronic health record systems, so it sits inside the reading workflow cardiologists and radiologists already use.
Built-in room to improve
One detail in the clearance matters to regulators more than to patients. It includes a Predetermined Change Control Plan, or PCCP. That lets a company “pre-clear” certain changes, so the machine learning models can be updated within agreed limits without a fresh 510(k) every time. The company says this helps keep performance current as more clinical data comes in.
Dr. Jeffrey Dendy, the company’s CEO and founder, is a cardiologist and an assistant professor of cardiovascular medicine at Vanderbilt University Medical Center. “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,” he said. He also pointed out that the product cleared on the first submission, PCCP included. Of the Innolitics team, he said: “They understood both the science and how FDA thinks.”
Medical Device Network noted the wider backdrop. A GlobalData report forecasts that AI in healthcare will reach a valuation of $57.4bn in 2029, and most AI-based devices on the FDA’s 2026 list are imaging products.
Heartvue.ai will now begin rolling the software out to US hospitals and imaging centers, building on its existing network of beta sites. The encouraging part is that a doctor stays in charge of every reading. Patients with heart conditions should talk to their doctor about which imaging is right for them.
Sources
- Heartvue.ai and Innolitics Achieve FDA 510(k) Clearance for Heartvue.Proton, an AI-Powered Cardiac MRI Analysis Platform – AOL
- FDA clears Heartvue’s cardiac image evaluation software
