C8 MediSensors has won CE Mark approval for its Optical Glucose Monitor System, a new non-invasive continuous glucose monitor (nCGM) for people with type 1 diabetes in Europe.
The nCGM is worn under clothes against the skin, and leverages the power of light to measure glucose levels.
A beam of light is shone into the skin using Raman spectroscopy and the resulting vibrations of glucose molecules will be measured for a glucose reading that appears on a pain-free portable monitor.
C8 MediSensors CEO Paul Zygielbaum said; "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."
The device can also store the readings and can send them wirelessly to the user’s smartphone, which provides a graphical overview of glucose dynamics throughout the day.
Clinical studies demonstrated that C8 MediSensors’ monitor was as accurate as previous versions of invasive CGMs, but with reduced pain and minimum risk of infection.
The adjunct device is contraindicated in pregnancy and for those with below 18 years of age, as well as for individuals with very light or very dark skin tones, or peripheral vascular disease.
