Arterys Gets FDA’s 510(k) Clearance for Cardiac MRI Artificial Intelligence Software

San Francisco, Calif.-based Arterys has received the FDA’s 510(k) clearance for the latest version of its Cardio AI (artificial intelligence) software for analysis of cardiac magnetic resonance imaging (MRI) scans.

The cloud-based software, which uses deep learning technology to deliver rapid analysis of MRI images, features new tools that allow physicians to easily quantify volumes for both the left and right atria. It also delivers wall-thickness measurements that are critical to the diagnosis process, the company said.

The software reduces the time taken for analysis from 30 or more minutes to “in many cases, before the patient is off the MRI table,” said Ali B Syed, a radiologist at the Stanford School of Medicine.