C8 MediSensors Noninvasive CGM Approved for Sale in Europe
C8 MediSensors’ nCGM approved for sale in Europe. The device sends readings to a smartphone.
A little over a year ago I first wrote about C8 MediSensors HG1-c noninvasive continuous glucose monitor (nCGM). This week I received word from the company that their device, which uses light to measure glucose in the interstitial fluid, has gained CE Mark Approval for sale in the European Union. European customers can reserve C8 MediSensors Optical Glucose Monitor System via the company’s website. In June, Chief Financial Officer Fred Toney said that the company has raised $19 million for its European launch, bringing the investor total to $60 million. Though most investors remain undisclosed, GE Capital and GE Healthcare, both divisions of General Electric Corp., have put money into the company.
After launching in Europe, the next step will be to begin the regulatory process with the U.S. Food and Drug Administration. The FDA could prove to be a bit of a challenge, given its reputation for playing politics. However, approval in Europe is the starting point that C8 MediSensors needed in order to get their noninvasive optical glucose monitor passed the FDA. The device will sell for around $4,000, which is less than the cost of invasive continuous glucose monitors (CGMs).
My name is Kevin Lang and I am a Type 1 Diabetic who was diagnosed in May of 2004 at the age of 27. My last A1C was 6.0 in May 2015. I used to use daily shots of Lantus and Novolog to control my blood sugar until I switched to the MiniMed Paradigm Revel Insulin Pump in February 2011. To learn more about me, follow the about link in the menu bar.
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.
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.
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
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.
Any recent news on this product?