Imricor (ASX: IMR) Receives FDA Clearance for Vision-MR Diagnostic Catheter

Key Highlights

• FDA grants 510(k) clearance for Imricor’s Vision-MR Diagnostic Catheter
• Clearance enables commercial marketing in the United States
• The approval represents Imricor’s first US regulatory clearance
• Shares rose 17.1% during Monday’s session
   

Imricor Medical Systems has received US Food and Drug Administration 510(k) clearance for its Vision-MR Diagnostic Catheter, allowing the company to commence commercial marketing of the device in the United States.

The clearance marks Imricor’s first regulatory approval in the US and represents a key step in its strategy to commercialise MRI-guided electrophysiology technologies in major global markets, according to the company’s ASX announcement released on Monday.

Regulatory Scope and Product Overview

The Vision-MR Diagnostic Catheter is designed for use in cardiac electrophysiology procedures performed under real-time magnetic resonance imaging. The device forms part of Imricor’s broader MRI-compatible electrophysiology platform, which aims to replace traditional X-ray fluoroscopy with MRI guidance.

Under the FDA’s 510(k) pathway, Imricor demonstrated that the Vision-MR catheter is substantially equivalent in safety and performance to legally marketed predicate devices, allowing it to be sold for clinical use in the US.

Market Size for Vision-MR Diagnostic Catheter in the USA

The Vision-MR Diagnostic Catheter is a newly cleared product entering the US electrophysiology (EP) market, specifically the segment for diagnostic catheters used in cardiac procedures. As a novel MRI-compatible device, its current market size is effectively zero since it’s just been approved for commercial sale. However, the addressable market is the broader US EP market, with a focus on diagnostic catheters, as the announcement positions the US as the world’s largest EP market.

• The overall US electrophysiology market is estimated at approximately USD 4.3 billion in 2025, with projections to grow to around USD 10.8 billion by 2033 at a CAGR of about 12.3%. This growth is driven by rising arrhythmia prevalence, advancements in minimally invasive technologies, and increasing adoption of EP procedures.

• More specifically, the US market for electrophysiology diagnostic catheters (the category Vision-MR falls into) was valued at over USD 700 million in 2023. With an estimated CAGR of around 10%, this segment could reach approximately USD 850 million by 2025. 

Management Commentary

Imricor Chair and Chief Executive Officer Steve Wedan said the approval represents an important regulatory milestone for the company.

Source: IMR ASX Announcement 

Market Context and Share Price Movement

Imricor shares surged by 17.09% at $1.85 on Monday, with trading volumes of approximately 978,000 shares. The company’s market capitalisation stood at approximately $594 million.

Over the past 12 months, the stock has gained around 48.6%, trading near the upper end of its 52-week range of $1.115 to $1.99.

Strategic Importance of the US Market

The United States represents the largest global market for electrophysiology procedures, supported by high procedural volumes and established reimbursement frameworks.

FDA clearance enables Imricor to engage directly with US hospitals and clinicians and may support broader commercial discussions, including distribution partnerships and further regulatory submissions. The company currently holds regulatory approvals for certain products in Europe and selected international markets.

Next Steps

The FDA clearance marks Imricor’s first regulatory approval in the United States, a jurisdiction widely regarded as the most demanding for medical device approvals. For healthcare companies, FDA clearance is not just a compliance milestone. It is a commercial gatekeeper that validates safety, manufacturing standards, and clinical credibility at a global level.

With this approval, Imricor is now permitted to market and sell its MRI-guided electrophysiology technology in the U.S., significantly expanding its addressable market beyond Europe and select international regions. The U.S. electrophysiology market is one of the fastest-growing segments in cardiology, driven by rising incidence of atrial fibrillation and increasing adoption of advanced imaging-guided procedures.

Imricor stated that it intends to continue progressing regulatory approvals for additional diagnostic and ablation products during 2026. The company is also continuing clinical, regulatory, and commercial preparation activities related to its MRI-guided electrophysiology platform.

While the FDA clearance enables initial market entry, future performance will depend on execution across regulatory expansion, clinical adoption, and commercial rollout.