FDA clears new imaging software from AI company founded by cardiologists
Heartvue.ai, a medtech company based in Tennessee, has secured U.S. Food and Drug Administration (FDA) clearance for its new artificial intelligence (AI)-enabled imaging software that views, processes and evaluates cardiac MRI scans. Innolitics, an Austin-based consulting firm, helped guide Heartvue.ai through the regulatory process.
The newly cleared software, Heartvue.Proton, uses advanced AI algorithms to automate measurements of 2D linear dimensions, ventricular volumes and ejection fraction, and blood flow quantification. Automating these measurements saves time, though each result is still reviewed and confirmed by a trained clinician. The software was designed to integrate with a hospital’s PACS or EHR system and slide right into any existing cardiology or radiology workflow.
This clearance also includes a Predetermined Change Control Plan (PCCP), which helps Heartvue.ai make specific updates to this software without submitting additional requests to the FDA.
“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,” Jeffrey Dendy, MD, Heartvue.ai co-founder and an assistant professor of cardiovascular medicine at Vanderbilt University Medical Center, said in a statement. “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.”
Heartvue.ai is already planning to kick off the commercial rollout of Heartvue.Proton. The company also has an echocardiography solution, Heartvue.Echo.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.