NASHVILLE — A Tennessee-based medical technology company founded by cardiologists has secured U.S. Food and Drug Administration clearance for artificial intelligence software that automates key measurements from cardiac MRI scans, a step the company says could broaden access to quantitative heart imaging while preserving clinician oversight. Heartvue.ai, headquartered in Tennessee, announced the FDA clearance for Heartvue.Proton. The software is designed to view, process, and evaluate cardiac MRI scans, automating measurements of two-dimensional linear dimensions, ventricular volumes, ejection fraction, and blood flow quantification.
According to the company, automating these measurements saves time, but each result is still reviewed and confirmed by a trained clinician. The software is intended to integrate with a hospital’s Picture Archiving and Communication System or Electronic Health Record system, allowing it to fit into existing cardiology or radiology workflows.
The FDA clearance also includes a Predetermined Change Control Plan. This permits Heartvue.ai to make specific updates to the software without submitting additional FDA requests.
Built by a Practicing Cardiologist
Dr. Jeffrey Dendy, co-founder of Heartvue.ai and an assistant professor of cardiovascular medicine at Vanderbilt University Medical Center, developed the tool from direct clinical experience. “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,” Dendy said. “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.” Innolitics, an Austin-based consulting firm, guided Heartvue.ai through the regulatory process.
What Comes Next
Heartvue.ai is planning the commercial rollout of Heartvue.Proton. The company also has an echocardiography solution called Heartvue.Echo in its portfolio. The company’s background includes a focus on cardiology and artificial intelligence, with team members having extensive experience in healthcare writing and editing.
The FDA clearance marks a significant step for a firm aiming to make quantitative cardiac MRI more accessible and to reduce the burden of manual measurements on clinicians. Consult your doctor for medical advice.
