Imricor Medical Systems (ASX: IMR) has lodged its Imricor Advantage-MR FDA submission, filing a 510(k) premarket notification application for the Advantage-MR EP Recorder/Stimulator system. The company already holds approvals in the European Union, Kingdom of Saudi Arabia, and New Zealand, with the US submission representing a critical step toward accessing the world’s largest healthcare market.
Imricor lodges FDA 510(k) application for Advantage-MR system
The Advantage-MR EP Recorder/Stimulator system has been submitted to the US Food and Drug Administration (FDA) via the 510(k) premarket notification pathway. This regulatory route is typically faster than more complex approval processes, making it a strategic choice for medical devices with comparable market equivalents.
The system is currently approved in three international jurisdictions:
- European Union: Approved
- Kingdom of Saudi Arabia: Approved
- New Zealand: Approved
For investors, FDA clearance would unlock access to the US healthcare market, materially expanding Imricor’s addressable opportunity. The company disclosed that approval is now in process, with further regulatory applications planned for Australia.
What is the Advantage-MR system and why does it matter?
The Advantage-MR system acquires, amplifies, filters, digitises, displays, and records electrical signals from the heart during electrophysiological studies and cardiac ablation procedures. It captures both intracardiac electrograms (signals detected inside the heart by catheters) and surface ECG readings.
The system’s key capabilities include:
- Intracardiac electrogram recording from diagnostic and ablation catheters
- Surface ECG capture for comprehensive cardiac monitoring
- MRI system interface compatible with Siemens and Philips (GE compatibility coming soon)
- Programmable cardiac stimulation via integrated pacemaker functionality
Imricor positions Advantage-MR as the connective tissue of its interventional cardiac magnetic resonance (iCMR) laboratories, integrating catheters, MRI systems, ablation generators, 12-lead ECG equipment, and the NorthStar mapping system. Critically, the company states that no other EP recording system on the market is safe for use in an MRI environment, giving Advantage-MR a differentiated technical position.
The MRI compatibility addresses a key clinical constraint. Traditional EP recording systems cannot function safely within the magnetic field of an MRI scanner, limiting procedural imaging options.
CEO commentary on strategic importance
Steve Wedan, Executive Chair, President and CEO
“I often say that NorthStar is the central hub of our iCMR labs. In a similar way, 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. Advantage-MR represents decades of multiple 3rd party technical and business collaborations.”
Wedan explained that Advantage-MR was initially developed because recording clean electrical signals from the heart is too challenging for any other EP recording system on the market, and none are safe for MRI use. The company integrated external cardiac stimulation functionality when no MRI-compatible alternatives existed.
How MRI-guided cardiac ablation works
Cardiac ablation treats irregular heart rhythms (arrhythmias) by delivering energy to destroy problematic heart tissue. Traditionally, these procedures rely on x-ray fluoroscopy for catheter guidance, exposing patients and clinicians to ionising radiation.
MRI-guided ablation offers superior soft tissue imaging without radiation exposure. The Advantage-MR system enables this by interfacing with MRI scanners from Siemens and Philips, allowing the MRI to detect miniature tracking receive coils embedded in Imricor’s Vision-MR catheters. The MRI systems then pass these tracking coil signals to Imricor’s NorthStar system for locating the catheters within the body.
This approach combines MRI’s imaging clarity with the electrophysiological mapping and stimulation capabilities of Advantage-MR, creating what the company describes as a complete iCMR lab solution.
For investors, the clinical preference for safer, radiation-free imaging supports the long-term demand thesis for MRI-compatible cardiac technologies. The company’s regulatory expansion reflects a transition from development to commercialisation.
Pathway to US commercialisation
The Imricor Advantage-MR FDA submission marks the company’s formal entry into the US regulatory process. The 510(k) pathway requires demonstrating substantial equivalence to a legally marketed predicate device, typically resulting in shorter review timelines than de novo applications.
Current regulatory status by geography:
- European Union: Approved
- Kingdom of Saudi Arabia: Approved
- New Zealand: Approved
- United States: FDA submission lodged (in process)
- Australia: Planned
The US clearance would provide access to the world’s largest medical device market. Imricor disclosed that FDA approval is now in process, with no specific timeline provided. The company also stated that further approvals in other geographies, including Australia, are being planned.
Imricor’s product portfolio includes capital equipment (NorthStar Mapping System and Advantage-MR EP Recorder/Stimulator) alongside single-use devices such as ablation catheters, diagnostic catheters, steerable sheaths, and other tools used for cardiac ablations. The Advantage-MR system underpins this ecosystem by enabling the MRI compatibility that differentiates Imricor’s offerings from traditional x-ray-guided alternatives.
Want the Next MedTech Breakthrough in Your Inbox?
Join 20,000+ investors receiving FREE real-time ASX healthcare alerts with in-depth analysis delivered within minutes of release. Click the “Free Alerts” button at Big News Blast to get breaking medtech, biotech, and pharmaceutical news the moment it hits the market.