Integrity Applications, maker of GlucoTrack, a non-invasive device for measuring glucose levels of people with Type 2 diabetes and pre-diabetics, today announced that it has received an extension of its ISO 13485:2003 certificate and Annex II certification from the European Union (EU).
The ISO 13485 certification signifies that the company has met the standards required for company-wide implementation of device quality management system(s). The scope of the certification is design, development, manufacture and service of non-invasive glucose monitoring system for home use. Annex II also addresses quality control systems.
The certification allows the company to self certify certain modifications and changes and simplifies some of the reporting to and review by the relevant Notified Body. This can shorten CE-mark review process of future GlucoTrack® Model DF-F enhancements or revisions. Without an Annex II certification, each new device enhancement or modified version would be subject to the full EU CE-mark review process.
One of the benefits of the ISO 13485:2003 and Annex II certifications is that these certifications can potentially improve the time to market for product sales on new, enhanced or modified GlucoTrack® Model DF-F devices.
GlucoTrack® is a non-invasive device for measuring glucose levels of people with Type 2 diabetes or at risk of developing diabetes that does not require pricking of the fingers to draw blood for daily glucose monitoring.
GlucoTrack® features a small sensor that clips to the earlobe and measures the wearer’s glucose level by taking measurements using three technologies. The measured signals are analyzed using a proprietary algorithm and displayed on a small handheld device, the size of a mobile phone. The derived glucose measurement is also announced verbally, facilitating use by elderly and vision-impaired diabetes patients.
The GlucoTrack® Model DF-F is expected to begin clinical trials for United States FDA approval in early 2016, subject to approval of Integrity Applications’ clinical trials protocol by the FDA.
GlucoTrack® Model DF-F obtained a CE Mark approval in Europe (June 2013) and final CE Mark approval in March 2014 and recently received approval to market the device also to pre-diabetics.
GlucoTrack® Model DF-F is currently under assessment with the China Food and Drug Administration (CFDA) as well as food and drug governing bodies in Japan, South Korea Canada and Australia.