Imricor Medical Systems achieves significant milestone
Imricor Medical Systems, Inc. surged more than 17% by afternoon trade on Monday after announcing its first FDA approval which boosted investor confidence in the rollout of its MRI-guided cardiac ablation platform.
Imricor Medical Systems, Inc. (ASX: IMR)
on 12 January 2026 announced that the U.S. Food and Drug Administration granted 510(k) clearance for its Vision-MR Diagnostic Catheter which marks the company’s first FDA approval.
The FDA clearance allows Imricor to commercially market the Vision-MR Diagnostic Catheter in the United States which is the world’s largest electrophysiology market.
This approval is expected to be the first of multiple regulatory clearances during the current calendar year as the company continues to introduce its full MRI-guided electrophysiology platform to the market.
On 19 December 2025, the company announced that Charite University Hospital in Berlin will become the second global site to participate in the VISABL-VT clinical trial.
Earlier on 4 November 2025, Imricor reported that Amsterdam University Medical Centre completed the world’s first in-human ischemic ventricular tachycardia ablation performed entirely under real-time MRI guidance in an iCMR laboratory.
This milestone reflects several years of collaborative development which combined Imricor’s medical device capabilities with the clinical expertise of the Amsterdam University Medical Centre team.
NorthStar was launched in Europe at the end of the September quarter and the European sales pipeline increased from 26 to 35 during the quarter.
Discussions with hospitals in the United States identified a larger-than-expected installed base of cardiology-controlled MRI scanners which supports longer-term commercial potential.
The company reported operating cash outflows of US$4.8 million for the September quarter and finished the period with total cash and short-term investments of US$45.7 million.
Imricor’s strategy works because it targets a clear unmet need in electrophysiology through a fully integrated MRI guided ablation platform that is hard to replicate and well positioned to gain from first mover advantage as hospitals move towards safer, image guided cardiac procedures.
(Source: Company Announcements)
Get Your Free Report on Top 5 ASX Stocks on WhatsApp
Instant Access. No Credit Card Required.
Receive on WhatsApp
Checkout Our Recommendation for free - 7 days free trial
Start Free TrialASX Stock Research & Recommendations — 7‑day free trial
Independent, analyst‑driven insights.
- Stock of the week report
- Daily Analysis Report
- No credit card required
Get Your FREE Report
Discover the Top ASX Stocks to Invest In 2026!
Expert Analysis of Top-Performing ASX Stocks
Market Insights and In-Depth Research
Buy, Sell, And Hold Recommendations
Almost There!
Enter your details to download the report
Success!
Preparing your download...
Latest Article
Disclaimer
Veye Pty Ltd(ABN 58 623 120 865), holds (AFSL No. 523157 ). All information provided by Veye Pty Ltd through its website, reports, and newsletters is general financial product advice only and should not be considered a personal recommendation to buy or sell any asset or security. Before acting on the advice, you should consider whether it’s appropriate to you, in light of your objectives, financial situation, or needs. You should look at the Product Disclosure Statement or other offer document associated with the security or product before making a decision on acquiring the security or product. You can refer to our Terms & Conditions and Financial Services Guide for more information. Any recommendation contained herein may not be suitable for all investors as it does not take into account your personal financial needs or investment objectives. Although Veye takes the utmost care to ensure accuracy of the content and that the information is gathered and processed from reliable resources, we strongly recommend that you seek professional advice from your financial advisor or stockbroker before making any investment decision based on any of our recommendations. All the information we share represents our views on the date of publishing as stocks are subject to real time changes and therefore may change without notice. Please remember that investments can go up and down and past performance is not necessarily indicative of future returns. We request our readers not to interpret our reports as direct recommendations. To the extent permitted by law, Veye Pty Ltd excludes all liability for any loss or damage arising from the use of this website and any information published (including any indirect or consequential loss, any data loss, or data corruption) (as mentioned on the website www.veye.com.au), and confirms that the employees and/or associates of Veye Pty Ltd do not hold positions in any of the financial products covered on the website on the date of publishing this report. Veye Pty Ltd hereby limits its liability, to the extent permitted by law to the resupply of services.
