Hello Zeno9The gaining of the CE Mark approval in Europe for...

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pistol08

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27/08/21

14:14

Post #: 55628326
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Originally posted by zeno9: ↑

Hi patientvalue

Yes NAN did make an announcement when they lodged the submission for trophon approval with the FDA.

The announcement was made on 13 May 2009 and indicated that the company had instructed its agent, Safis Solutions, to lodge a 510K application with the FDA for trophon approval. The NAN announcement stated that FDA expected to provide an initial review and feedback within 90 days of lodgement, and that was done by 10 July 2009, with NAN given 30 days to respond to FDA's initial review.

The NAN announcement also implied that the submission had been earlier delayed because of FDA requirements at the time for further extensive microbiological testing of the trophon device.

Notice of FDA approval for trophon was advised by NAN on 28 February 2011 - nearly 21 months later.

I would expect that the FDA approval process for the Nanosonics Coris endoscope cleaning product would be of a similar duration but given the amount of time this new product has been in development, it might be reasonable to also expect that the company is not too far away from being able to announce lodgement of a submission for Coris approval with the FDA.

The process for gaining CE Mark approval in Europe for Nanosonics Coris should be much quicker, as the timetable for trophon CE Mark was only 6 months from submission lodgement to application approval. So, it wouldn't surprise me if the European market for Coris gets a green light from the European regulator long before the FDA has finished its process. Furthermore, unlike with trophon which has required a raft of country specific guidelines in Europe on high level disinfection of ultrasound transducers before it generated any significant commercial interest, endoscope cleaning is already an integral and routine part of endoscope reprocessing in every jurisdiction - albeit a somewhat unreliable and cumbersome part of the process. Therefore, if the regulator CE Mark's Nanosonics Coris in Europe in a timely fashion, that should clear the way for a much quicker take-up of that product in Europe than has been the case in Europe with the take-up of Nanosonics trophon.

zeno9

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Hello Zeno9
The gaining of the CE Mark approval in Europe for Nanosonics Coris, will that also cover Great Britain in view of Brexit or is that a separate process?

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