Integrity Applications has received CE Mark approval from Dekra Certification, its notified body in the EU, to extend its claim from a monthly recalibration to a six-month calibration validity of the GlucoTrack model DF-F noninvasive blood glucose measurement device.
With this extended validity, the initial calibration of the GlucoTrack model DF-F device will be valid for the entire six-month approved lifespan of the Personal Ear Clip (PEC), adding yet another important advantage to using GlucoTrack DF-F. Prior to receiving this validation, Integrity had obtained a CE Mark for GlucoTrack DF-F in Europe based upon a monthly recalibration.
Integrity Applications president and CEO Avner Gal noted official confirmation of the company’s claim that the calibration of GlucoTrack model DF-F is valid for a full six months is a major advantage of its device, as users are now only required to calibrate the device twice a year, when they replace the PEC.
"Recalibration is a major hurdle in noninvasive measurements, especially in noninvasive glucose monitors, and to the best of our knowledge, GlucoTrack is the only glucose monitoring device with this feature," Gal added.
GlucoTrack features a small sensor that clips to the earlobe and measures the wearer’s blood glucose level by taking measurements using three technologies. The measurements are analyzed using a proprietary algorithm and displayed on a small handheld device, the size of a mobile phone.
The derived blood glucose measurement is also announced verbally, making it suitable for the elderly and vision-impaired diabetes patients. The company has obtained a CE Mark for its GlucoTrack Model DF-F in Europe (June 2013) and intends to seek US Food and Drug Administration approval for GlucoTrack in the US.