Imricor Submits Advantage-MR System for FDA 510(K) Clearance
| Stock | Imricor Medical Systems Inc (IMR.ASX) |
|---|---|
| Release Time | 6 Feb 2026, 8:53 a.m. |
| Price Sensitive | Yes |
Imricor Submits Advantage-MR System for FDA 510(K) Clearance
- Imricor has submitted its Advantage-MR EP Recorder/Stimulator system for FDA 510(k) clearance
- The Advantage-MR system is an MR Conditional electrophysiology (EP) mapping system
- The system connects all components of Imricor's iCMR labs, including catheters, MRI systems, and ablation generator
Imricor Medical Systems, Inc. (ASX: IMR) has announced that it has submitted its Advantage-MR EP Recorder/Stimulator system for market clearance under the U.S. Food and Drug Administration's (FDA's) 510(k) premarket notification pathway. The Advantage-MR system is an MR Conditional electrophysiology (EP) mapping system, used to acquire, amplify, filter, digitize, display, and record electrical signals obtained during electrophysiological studies and ablations. The system also provides a hardware and software interface for MRI systems from Siemens and Philips, with GE coming soon, allowing the MRI systems to identify and utilize miniature tracking receive coils embedded in Imricor's Vision-MR catheters. Imricor's Chair and CEO, Steve Wedan, commented that the Advantage-MR system is the 'glue that brings all of the components of iCMR together, including the catheters, MRI systems, the ablation generator, the 12-lead ECG, and NorthStar'. The system not only provides EP recording and programmable cardiac stimulation in the MRI environment, but also connects all of the iCMR systems and devices to create a complete and comprehensive iCMR lab solution.