Integrity Applications has announced that it has received CE Mark approval from Dekra Certification B.V., its Notified Body in the European Union for improvements to the GlucoTrack model DF-F noninvasive glucose measurement device.
As a result of these improvements, the calibration process for the device, which previously required eight finger stick measurements as a reference and took approximately two and half hours to complete, now requires just three finger stick measurements and takes less than thirty minutes to complete.
These improvements are expected to greatly enhance the user experience and allow for doctors and clinicians to calibrate more users, more expeditiously, which is expected to reduce or eliminate any backlog created as new device users await calibration.
In addition, the Notified Body has approved an expansion of the intended use of the GlucoTrack model DF-F to allow for the marketing of the device to the pre-diabetic population as well.
"Shortening the calibration time is a meaningful improvement to the practicality of the device and for its usability," said Prof. Lutz Heinemann, Ph.D, Chairman of Integrity’s Scientific Advisory Board.
"The updated intended use is extremely significant for the Company; providing those suffering from pre-diabetes a tool to monitor his or her glucose levels is crucial for postponing, or even preventing diabetes from developing."
Avner Gal, President and CEO of Integrity Applications, said, "This is a great day for the Company. Receiving the CE Mark approval for these improvements is extremely exciting for us. We believe that a calibration process requiring only three finger stick measurements, takes less than thirty minutes and still valid for six months is a major breakthrough for non-invasive glucose monitoring."