Imricor Advances Toward Full U.S. Commercial Platform with Latest FDA Filings
Imricor Medical Systems (ASX: IMR) has taken another step toward expanding its presence in the United States by submitting its NavTrac and NavTrac-MR steerable introducer systems for clearance under the U.S. Food and Drug Administration’s 510(k) pathway. These devices are designed to assist physicians in guiding cardiovascular catheters during heart procedures, with one version specifically developed for MRI-guided environments. The latest submissions follow recent FDA approvals for the company’s NorthStar system and Vision-MR Diagnostic Catheter, strengthening its regulatory progress.
The new filings mean every Imricor product requiring the 510(k) process has now either received FDA clearance or has been submitted for review. Overall, the company has completed 14 of the 15 regulatory submissions needed to establish its full commercial platform in the U.S. Management believes this progress supports wider adoption of MRI-guided cardiac procedures and could accelerate installations across hospitals while paving the way for future approvals of its broader electrophysiology portfolio.
Customer Notice:
Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.
Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com.au
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Imricor Advances Toward Full U.S. Commercial Platform with Latest FDA Filings
Imricor Medical Systems (ASX: IMR) has taken another step toward expanding its presence in the United States by submitting its NavTrac and NavTrac-MR steerable introducer systems for clearance under the U.S. Food and Drug Administration’s 510(k) pathway. These devices are designed to assist physicians in guiding cardiovascular catheters during heart procedures, with one version specifically developed for MRI-guided environments. The latest submissions follow recent FDA approvals for the company’s NorthStar system and Vision-MR Diagnostic Catheter, strengthening its regulatory progress.
The new filings mean every Imricor product requiring the 510(k) process has now either received FDA clearance or has been submitted for review. Overall, the company has completed 14 of the 15 regulatory submissions needed to establish its full commercial platform in the U.S. Management believes this progress supports wider adoption of MRI-guided cardiac procedures and could accelerate installations across hospitals while paving the way for future approvals of its broader electrophysiology portfolio.
Customer Notice:
Nextgen Global Services Pty Ltd trading as Kapitales Research (ABN 89 652 632 561) is a Corporate Authorised Representative (CAR No. 1293674) of Enva Australia Pty Ltd (AFSL 424494). The information contained in this website is general information only. Any advice is general advice only. No consideration has been given or will be given to the individual investment objectives, financial situation or needs of any particular person. The decision to invest or trade and the method selected is a personal decision and involves an inherent level of risk, and you must undertake your own investigations and obtain your own advice regarding the suitability of this product for your circumstances. Please be aware that all trading activity is subject to both profit & loss and may not be suitable for you. The past performance of this product is not and should not be taken as an indication of future performance.
Kapitales Research, Level 13, Suite 1A, 465 Victoria Ave, Chatswood, NSW 2067, Australia | 1800 005 780 | info@kapitales.com.au