Noninvasive glucose monitoring device GlucoTrack starts its regulatory journey with the FDA


Israel-based Integrity Applications has started the journey with the FDA to bring its noninvasive glucose monitoring device called GlucoTrack to the United States.

Said device comes in the form of a clip the user places on his or her ear, and from there, GlucoTrack is able to determine blood glucose level without drawing blood. The information collected is then sent to another device about the size of a smartphone, which displays the readings and can even announce them verbally to visually impaired users. The ear clip still has to be calibrated every six months in the process that requires drawing blood.

GlucoTrack does its magic by performing three independent measurements simultaneously, using thermal, ultrasound, and electromagnetic technologies; and results are weighted using a patented algorithm to (reportedly) provide accurate readings.

The (GlucoTrack) technology already got a CE Mark and is available in some other countries.The technology already got a CE Mark and is available in some other countries, but the journey to the U.S. market will take some time. Integrity Applications has filed pre-submission documents, asking for FDA’s feedback on planned US-based clinical trials, which will apparently include a well-known hospital and university. The company will need to complete those trials before actually submitting the technology for FDA clearance.

Meanwhile, we’ve seen other similar efforts to noninvasively monitor glucose levels, the most well-known being the one from Google and Novartis. This (dynamic) duo is working on a glucose-sensing contact lens, which is still in the nascent phase and we’ll likely have to wait for another year (or so) before we see it hitting the market.

[Via: mobihealthnews]