Integrity Applications has submitted pre-submission documents for the GlucoTrack model DF-F noninvasive blood glucose measurement device to US Food and Drug Administration (FDA).
Documents were submitted in connection with the device’s proposed future application for FDA approval of its US clinical trial protocol.
The documentation seeks to obtain the agency’s guidance regarding the US regulatory pathway for the device, the proper approach to refining trial protocol and endpoints, and preparing the pre-marketing application.
Integrity Applications president Avner Gal said: "This is an exciting time for the company as we take the necessary steps to seek to bring the advantages of the GlucoTrack model DF-F non-invasive glucose monitor to the US market."
If the FDA approves the clinical trial protocol, the company hopes to start clinical trials in the US in early 2016.
The company is believed to be currently in talks with a well-known hospital and university to conduct such clinical trials, but a final agreement is yet to be signed.
GlucoTrack model DF-F is an investigational device, and features a small sensor that clips to the earlobe and measures the wearer’s blood glucose level by taking measurements using three technologies.
The derived blood glucose measurements are analysed using a proprietary algorithm and displayed on a small handheld device, and can also be announced verbally, making it suitable for the elderly and vision-impaired diabetes patients.
Integrity obtained a CE Mark for the device in Europe in June 2013, and final CE Mark approval in March 2014. The device is currently unavailable for sale in the US.
The FDA’s pre-submission programme aims to provide applicants with the opportunity to obtain targeted FDA feedback in response to specific questions related to product development, including planned non-clinical evaluations, proposed clinical study protocols or data requirements, before making a submission to the agency.