Roche withdrawing FDA submission
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Now that Roche has decided to withdraw their FDA submission for their meters to be used on critically ill patients, I am curious as to what other places will be doing now - sticking with Roche or switching to Nova?
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We just finished an RFP for new glucometers. We are switching to NOVA, and one of the main reasons was the issue with not being able to use the AccuChek on critically ill patients.
We are currently using the iSTAT on critically ill patients, so switching to NOVA will be a cost savings with eliminating the iSTAT glucose cartridges.
Karen,
Where did you find this information? Is it on the FDA website? Did it come from a sales rep?
Let me know. Thanks. Deanna Bogner
Yes, our sales rep told us before we got the official letter from Roche stating that they "have made the difficult decision to not re-submit the 510(k) application and to no longer pursue a critically ill claim for Accu-Chek Inform II." We were told that they are putting their resources towards a new platform that will come out in 2022. Hope this is helpful.