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Imricor Wins First FDA Clearance, Opening US Market for MRI-Guided EP Catheter

Story Highlights
  • Imricor secured its first FDA 510(k) clearance for the Vision-MR Diagnostic Catheter, a key MRI-guided electrophysiology device.
  • The clearance opens access to the US electrophysiology market and paves the way for further approvals of Imricor’s MRI-guided EP platform.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Imricor Wins First FDA Clearance, Opening US Market for MRI-Guided EP Catheter

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Imricor Medical Systems, Inc. Shs Chess Depository Interests Repr 1 Sh ( (AU:IMR) ) has issued an update.

Imricor Medical Systems has received its first-ever clearance from the US Food and Drug Administration for the Vision-MR Diagnostic Catheter, an MRI-guided electrophysiology device that forms a key element of its MRI-compatible EP platform. The 510(k) clearance allows Imricor to begin commercially marketing the catheter in the United States, the world’s largest electrophysiology market, marking a significant milestone in its US market entry and setting the stage for additional regulatory clearances as the company rolls out its full MRI-guided EP portfolio, with potentially meaningful implications for its growth trajectory and competitive positioning in advanced cardiac ablation technologies.

The most recent analyst rating on (AU:IMR) stock is a Buy with a A$2.22 price target. To see the full list of analyst forecasts on Imricor Medical Systems, Inc. Shs Chess Depository Interests Repr 1 Sh stock, see the AU:IMR Stock Forecast page.

More about Imricor Medical Systems, Inc. Shs Chess Depository Interests Repr 1 Sh

Imricor Medical Systems, Inc. is a medical technology company focused on making interventional procedures better, safer and more cost-effective by enabling them to be performed under real-time MRI guidance instead of traditional X-ray fluoroscopy. The company is a pioneer in MRI-compatible products for cardiac catheter ablation procedures, offering capital equipment such as the NorthStar Mapping System and Advantage-MR EP Recorder/Stimulator, along with a range of single-use ablation and diagnostic catheters, steerable sheaths and related tools, with approvals already secured in the EU, Saudi Arabia and New Zealand and further geographic expansion planned.

Average Trading Volume: 192,377

Technical Sentiment Signal: Strong Buy

Current Market Cap: A$506.3M

For a thorough assessment of IMR stock, go to TipRanks’ Stock Analysis page.

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