FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals / Research and Development

Integrity Applications Advances in FDA Approval Process for GlucoTrack

Nov. 2, 2015

Integrity Applications announced that it has met with the FDA to discuss clinical trial protocol for its GlucoTrack Model DF-F. 

GlucoTrack is a non-invasive device designed for measuring glucose levels of people with Type 2 diabetes or at risk of developing diabetes.

The company submitted pre-submission documents to the FDA in August, including the U.S. clinical trial protocol.

Integrity expects to begin clinical trials in the United States in early 2016. — Michael Cipriano