CE Mark For Novel Optical Glucose Monitor™Is A Fine Legacy For Inventor

In short

A new non-invasive continuous glucose monitor is available for marketing in Europe with the news that C8 MediSensors, Inc. has received CE Mark approval for its non-invasive Optical Glucose Monitor System.

Background

It’s quite a story. The founder of C8 Medisensors Inc was a chap called Jan Lipson, who’s quest was driven by the fact that his son was diabetic and found it difficult to control his glucose levels. A good understanding of glucose levels is invaluable in managing diabetes and improving patient outcomes in diabetics.

The great sadness is that Jan Lipson was killed in a cycling accident in 2010, but it seems his legacy is anything but insignificant as the company he co-founded has now seen its device approved for commercialisation in Europe.

Continuous Glucose Monitoring (CGM) devices are designed to act adjunctively with 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.

In clinical studies, the C8 MediSensors monitor was found to have accuracy comparable to earlier versions of invasive CGMs when those systems were first introduced, but with less pain and less risk of infection.

Company comments

“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 nCGM and the Optical Glucose Monitor System available throughout Europe.”

Availability

The C8 MediSensors Optical Glucose Monitor System will initially be available for purchase online via the C8 MediSensors website, here.

Regulatory warnings/precautions

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.

Source: C8 MediSensors, Inc., PR Newswire