FDA Clears AI Software for Automated Measurements on Cardiac MRI

The Food and Drug Administration (FDA) has granted 510(k) clearance for Heartvue.Proton, an AI-powered software that provides automated measurements for radiologists interpreting cardiac MRI scans.

Heartvue.ai, the developer of the software, said the Heartvue.Proton software alleviates the burden of manual measurements of cardiac MRI scans with automated measurements of ventricular volumes, ejection fraction and blood flow quantification.

“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,” noted Jeffrey Dendy, MD, the CEO and founder of Heartvue.ai.

In addition to facilitating integration into existing PACS systems, EHR platforms and radiology workflows, the Heartvue.Proton software has a predetermined change control plan, which allows Heartvue.ai to “pre-clear” certain algorithm changes without necessitating separate FDA clearances, according to the manufacturer.

(Editor’s note: For related content, see “Optimizing MRI Workflows: Eleven Takeaways from a New Literature Review,” “The ‘Biological Opportunity of Decreasing Voxel Size with Cardiac MRI and Photon-Counting CT” and “Can DSC MRI-Derived Oxygen Ejection Fraction Predict Diffusion Reversal in Patients Treated for Acute Ischemic Stroke?”)