FDA clears MRI-compatible EP mapping catheter
Imricor Medical Systems, a Minneapolis-based medtech company, has received U.S. Food and Drug Administration (FDA) clearance for its Vision-MR Diagnostic Catheter. This represents the company’s first FDA clearance since opening its doors in 2006.
The Vision-MR Diagnostic Catheter was built to be provide real-time electrophysiological mapping during under MRI guidance. According to Imricor, this helps electrophysiologists “harness the unmatched soft tissue imaging of the MRI” to visualize a patient’s cardiac anatomy prior to ablation procedures.
“This is obviously a tremendous milestone for the Imricor team, and I want to acknowledge the outstanding work of the entire team in reaching this achievement,” Steve Wedan, Imrico’s chair and CEO, said in a prepared statement. “Most of us have worked at companies that have existing medical devices on the U.S. market, and getting a new device on the market is always a big deal. But getting a company’s first device on the U.S. market is an extraordinarily big deal. It’s an exciting achievement and a date to be noted and remembered.”
Image courtesy of Imricor Medical Systems. Watch a full video here.
In June 2025, Imricor launched both the Vision-MR Diagnostic Catheter and the Vision-MR Ablation Catheter 2.0 in Europe. Both devices are currently being evaluated in the VISABL-AFL and VISABL-VT clinical trials.
Imricor hopes to progressively introduce its MRI-compatible electrophysiology platform to the United States over the next several months through a series of regulatory approvals. The goal is to allow care teams to perform entire cardiac ablations procedures under real-time MRI guidance with the patient inside the scanner.
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.