12 January 2026 – Minneapolis, MN, Imricor Medical Systems, Inc. (Company or Imricor) (ASX: IMR) is pleased to announce that the United States Food and Drug Administration (FDA) has granted 510(k) clearance for the Company’s Vision-MR® Diagnostic Catheter under the premarket notification process.
This marks the Company’s first FDA clearance.
The Vision-MR Diagnostic catheter is designed to be used under real-time magnetic resonance imaging (MRI) guidance and represents a key component of Imricor’s comprehensive platform of MRI-compatible electrophysiology (EP) devices.
FDA clearance enables Imricor to commercially market the Vision-MR Diagnostic Catheter in the United States, the world’s largest electrophysiology market. This clearance is the first of many regulatory milestones for this calendar year, as Imricor’s full MRI-guided EP platform is progressively introduced to the market.
Imricor’s Chair and CEO, Steve Wedan, added:
“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. Most of us have worked at companies that have existing medical devices on the US market, and getting a new device on the market is always a big deal. But getting a company’s first device on the US market is an extraordinarily big deal. It’s an exciting achievement and a date to be noted and remembered.”