www.fdanews.com/articles/195591-integrity-nabs-ce-mark-for-glucose-measuring-device
Integrity Nabs CE Mark for Glucose Measuring Device
January 22, 2020
Integrity Applications earned a CE Mark for an enhanced GlucoTrack, a non-invasive device for measuring glucose levels in people with Type 2 diabetes and prediabetes.
The enhanced device allows for a user to perform the calibration process by themselves, without the need for a certified calibrator.
The initial CE Mark approval required a calibration process that took three hours to complete, required eight invasive finger stick reference measurements, needed to be repeated every thirty days and required a certified calibrator.
The calibration process now takes just thirty minutes, requires just three invasive reference measurements, and needs to be repeated only once every six months.