Comments on: C8 MediSensors Noninvasive CGM Approved for Sale in Europe http://www.mevsdiabetes.com/c8-medisensors-noninvasive-cgm-approved-for-sale-in-europe/ The highs & lows of life with Type 1 Diabetes Mon, 31 Aug 2015 14:04:21 +0000 hourly 1 https://wordpress.org/?v=4.2.38 By: Liz http://www.mevsdiabetes.com/c8-medisensors-noninvasive-cgm-approved-for-sale-in-europe/#comment-15973 Mon, 31 Aug 2015 14:04:21 +0000 http://www.mevsdiabetes.com/?p=202#comment-15973 Any recent news on this product?

]]> By: Kev http://www.mevsdiabetes.com/c8-medisensors-noninvasive-cgm-approved-for-sale-in-europe/#comment-762 Fri, 04 Jan 2013 17:54:21 +0000 http://www.mevsdiabetes.com/?p=202#comment-762 Isabel, unfortunately, I do not know anyone who has tried C8’s nCGM. It has not been approved by the FDA yet here in the US. As a result, I can’t even reserve one at the moment. Please comment here again or write to me directly after you receive the unit. I would love to know what you and your son think of it.

Thanks.

]]> By: isabel http://www.mevsdiabetes.com/c8-medisensors-noninvasive-cgm-approved-for-sale-in-europe/#comment-761 Thu, 03 Jan 2013 22:25:40 +0000 http://www.mevsdiabetes.com/?p=202#comment-761 Hi Kevn

Thnaks for making this blog, my sun is a type 1 dabetic and this are very good news .
i have made a reservation today of the C8 and i realy hope it will lelp him a lot .
can you tel me if you have already tried it or if you know any one that is wearing it ?

thank you
regards
Isabel

]]> By: Kev http://www.mevsdiabetes.com/c8-medisensors-noninvasive-cgm-approved-for-sale-in-europe/#comment-712 Sun, 11 Nov 2012 16:11:11 +0000 http://www.mevsdiabetes.com/?p=202#comment-712 Betty, basically it comes down to bureaucracy and the fact that it can often take one to three years longer to get a new medical device approved in the U.S. than in the European Union. Another factor is that the FDA requires evidence of both the safety and efficacy of the device, while the E.U. requires only proof of safety. Politics and an inconsistency with regard to regulation are also a problem with the FDA. For all these reasons and more, bio-pharmaceutical and medical device start-ups have seen a significant decrease in funding over the past three years, which could make the issue even worse.

]]> By: Betty http://www.mevsdiabetes.com/c8-medisensors-noninvasive-cgm-approved-for-sale-in-europe/#comment-711 Sun, 11 Nov 2012 01:01:12 +0000 http://www.mevsdiabetes.com/?p=202#comment-711 Do you know why this EU is always getting the fun stuff first? I’ve noticed this with a lot of diabetes technology out there.

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