Integrity Applications Submits Presubmission Documents to FDA for GlucoTrack DF-F
Israeli devicemaker Integrity Applications has submitted presubmission documents to the FDA for its GlucoTrack DF-F system to gain guidance on the appropriate clinical trial design and endpoints.
The noninvasive glucose monitoring device features a small sensor that clips to the earlobe and measures the wearer’s glucose level using three technologies, Integrity says.
If the FDA approves the protocol, Integrity plans to begin trials early next year. The firm says it is in advanced talks with a well-known hospital and university to conduct the studies.
The FDA encourages firms to use its presubmission program to get feedback on issues related to product development prior to making a formal submission to the agency.
GlucoTrack DF-F received CE mark approval in March 2014. — Meg Bryant