Integrity Applications Receives CE Mark Approval for Calibration Validity of GlucoTrack

Integrity Applications Inc., developer of the GlucoTrack model DF-F noninvasive blood glucose measurement device, received CE Mark approval from Dekra Certification B.V., its Notified Body in the European Union, to extend its claim from a monthly recalibration to a six-month calibration validity of the GlucoTrack model DF-F 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 an 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.

“Official confirmation of our claim that the calibration of GlucoTrack model DF-F is valid for a full six months is a major advantage of our device, as users are now only required to calibrate the device twice a year, when they replace the PEC,” Avner Gal, President and CEO of Integrity Applications, said. 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.”

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 in June 2013 and intends to seek U.S. Food and Drug Administration approval.

Integrity Applications Inc. is a medical device company focused on the design, development and commercialization of non-invasive glucose monitoring devices for use by people with diabetes. Integrity Applications has developed the GlucoTrack model DF-F non-invasive glucose monitoring device, which is designed to help people with diabetes obtain blood glucose level measurements without the pain, inconvenience, incremental cost and difficulty or discomfort of conventional (invasive) spot finger stick devices. Integrity Applications works primarily through its wholly-owned Israeli subsidiary, A.D. Integrity Applications,