Integrity Applications, maker of GlucoTrack, a non-invasive device for measuring glucose levels of people with Type 2 diabetes and pre-diabetics, announced that it has received the final regulatory approval required to market and sell the GlucoTrack model DF-F in South Korea.
The Company had recently disclosed that it had received initial regulatory approval from the Korean Ministry of Food and Drug Safety (KMFDS, formerly KFDA) for the GlucoTrack® model DF-F; however, prior to commencing sales the Company would be required to undergo a GMP (Good Manufacturing Practice) audit.
The audit has been completed and the Company has now received final approval to begin selling the device.
In addition, the Company announced that its South Korean distribution partner placed an immediate initial order for 100 GlucoTrack® model DF-F units upon receipt of the KMFDS' regulatory approval.
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.