Imricor Medical Systems (ASX:IMR) Submits Second FDA PMA Module
FDA Submission
Imricor Medical Systems has submitted the second Premarket Approval module for FDA review, covering design and manufacturing processes for seven devices.
Upcoming Submissions and Market Launch
The company plans to submit its NorthStar 3D mapping system under the 510(k) process and expects US commercial availability in early Q3, with a European launch mid-year.
Executive Comments
CEO Steve Wedan stated, “We had set an internal deadline for the manufacturing module to be submitted by the end of February, and the team came through again, keeping us on track. It is difficult to convey how much work is involved due to the number of devices for which we are seeking approval simultaneously. We are now one step closer to getting the entire platform of technology on the market in the US. Again, I commend our Regulatory team, as well as our Quality and Manufacturing teams for this tremendous milestone. We look forward to working closely with the FDA as we continue towards full submission and market entry. The Company remains on track for the submission of the remaining modules in line with its planned timeline and will continue to update the market on further developments.”
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