We’ve been covering news of the GlucoTrack non-invasive glucometer for almost a decade now, and finally Integrity Applications, the company behind the device, is moving toward clinical trials potential regulatory approval in the U.S. The Israeli firm already received the CE mark in Europe for the GlucoTrack model DF-F two years ago, and the same device is in the pre-submission documents filed with the FDA.
The GlucoTrack uses an ear lobe clip-on similar to pulse oximeters to spot glucose levels through the skin. The sensor uses three different technologies to estimate blood glucose and sends its readings to a smartphone-like device that displays the numbers and keeps track of previous tests.
The latest documentation handed by Integrity Applications will help the FDA provide guidance to the firm in setting up a trial and filling out the pre-market application. Pending approval of a trial protocol, the company hopes to begin trials of the GlucoTrack early next year.
Here’s a promo video for the GlucoTrack
Flashbacks: GlucoTrack DF-F Noninvasive Glucose Meter Receives CE Mark…; Non-Invasive Measurement of Blood Glucose Levels Using GlucoTrack: Interview with CEO Avner Gal…; The GlucoTrack; GlucoTrack Ear Lobe Non Invasive Glucometer…
Press release: Integrity Applications…
(hat tip: MobiHealthNews)