First Possible Non-Invasive Continuous Glucose Monitor Approved in Europe

C8 MediSensors, Inc. has received Europe’s CE Mark approval for its Optical Non-Invasive CGM System….

A large number of studies have shown that continuous glucose monitors (CGM) can improve glycemic control with reduced risk of hypoglycemia. CGMs are adjunct devices that are intended to complement finger stick blood glucose tests. Traditional CGMs rely on a needle sensor inserted under the skin, which can cause pain or discomfort, and pose a risk of infection. In contrast, the C8 MediSensors Optical Glucose Monitor System harnesses the power of light to measure glucose levels. Using Raman spectroscopy, a beam of light is shone into the skin and the resulting vibrations of glucose molecules are measured to give a glucose reading; all achieved via a small, pain-free portable monitor, discreetly worn under clothes against the skin.

For added convenience these readings are stored and sent wirelessly to the user’s smartphone for glucose readings at a glance, providing the wearer with a continuous picture of glucose dynamics throughout the day. A good understanding of glucose levels is invaluable in managing diabetes and improving patient outcomes. In clinical studies, the C8 MediSensors monitor was found to have accuracy comparable to earlierversions of invasive CGMs when those systems were first introduced, but with less pain and less risk of infection.

"C8 MediSensors was co-founded by a father trying to help his son living with diabetes, and as a company, we remain dedicated to helping those with the disease," said Paul Zygielbaum, CEO of C8 MediSensors. "CE Mark approval is a landmark step for this unique technology. Our team is hugely excited to be working to make CGM and the Optical Glucose Monitor System available throughout Europe."

The C8 MediSensors Optical Glucose Monitor System is not yet shipping but will soon be available for purchase online via the C8 MediSensors website only to those in Europe.

The C8 MediSensors Optical Glucose Monitor System is an adjunct device. It is contraindicated in pregnancy and for those under 18 years of age, as well as in individuals with very light or very dark skin tones, peripheral vascular disease or individuals who smoke.