C8 MediSensors Noninvasive CGM Approved for Sale in Europe
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).