Integrity Applications said that GlucoTrack Link wireless module has received CE approval, further enhancing its non-invasive device for measuring glucose levels in people with type 2 diabetes and pre-diabetes.
Integrity Applications has achieved several product development milestones to further support GlucoTrack’s path to commercialization.
The company said its new wireless module, GlucoTrack Link, is now fully approved and lab certified, marking an important enhancement of the capabilities of the GlucoTrack system.
GlucoTrack is a non-invasive monitoring device that can measure and display the glucose level in about a minute without finger prick or any pain.
It has a small sensor that clips to the earlobe and measures the user’s glucose level using new and patented sensor technologies.
The signals that are measured will be analyzed using proprietary algorithm and then calculates glucose level is displayed on small handheld device, whose size of a small mobile phone. The glucose results are stored in the device and used to estimate HbA1c level. The device can also display glucose values graphically, to enable users to monitor glucose levels over time.
It has secured CE Mark in Europe and approval from the Ministry of Food and Drug Safety in South Korea for type 2 diabetes and pre-diabetics. It is currently available in selected markets in Europe and Asia.
The company stated that its product has passed all the tests and complies with the fourth edition of IEC 60601-1-2 standard. This updated international standard defines the basic and essential performance of medical equipment and will replace the existing IEC standard at the end of this year.
After this time, such medical devices that do not comply with the new standard cannot be sold in Europe or the US.
Furthermore, the company has also passed renewal audit for CE Marking to assess conformity to ISO 13485:2016 and Medical Device Directives, for the GlucoTrack system, including Annex ll capabilities to ensure full quality assurance system.
ISO 13485 is an internationally recognized and harmonized QMS standard, which was developed for medical device companies to provide guidance and tools for creating effective quality management system to ensure product and service performance.
Integrity Applications president and chief operating officer David Podwalski said: “Achievement of these milestones is essential to accelerating GlucoTrack commercialization in Europe, providing care providers and consumers with a reliable, seamless solution.
“GlucoTrack is a unique non-invasive glucose monitoring solution that eliminates painful finger pricks allowing patients to test themselves easily and more frequently as part of an integrated diabetes management approach.”