thanks for the info. I just don’t get it, but maybe good for some people.
The trials have been running here in Europe for some time now. We also got approved for 6 months version. I think that not worrying about sensor will be welcome change. I mean you got it done, and you are good for next 6 months. You c can go swim whenever you want, without having to change sensor afterwards. I am one of those users that extend Dexcom sensor as long as I can (3-4 weeks for me), so I have currently forego all stuff that has to do with prolonged contact with water (which I don’t like at all).
Interesting info from the Senseonics CEO from just a few days ago. Obviously in the ramp-up stage. FDA submission in place for the 90-day version of the product. The 180-day version has already been approved for in Europe as mentioned by @AndyRozman.
Currently, we have nearly 2,000 unique users on Eversense. Based on our early data from our post-market approval study, sensor reinsertion rates can be characterized as the following. Of those users that have had an opportunity to reinsert a sensor, 77% are reinserting a second sensor. Those transitioning from the second to the third or the third to the fourth, reinsertions are occurring at about a 90% rate. And encouragingly, for those transitioning from fourth to fifth, fifth to sixth and sixth to seventh, we’re seeing a 100% reinsertion rate.
Approved.
In a unanimous 8 - 0 vote, the FDA’s Clinical Chemistry and Clinical Toxicology Devices Panel recommends approval for Senseonics’ Eversense CGM system, designed to provide continuous blood sugar levels for 90 days.