The Integrity Applications, the company behind the GlucoTrack model DF-F noninvasive glucose measurement device, is moving toward clinical trials potential regulatory approval in the U.S.
The Israeli firm already received the CE mark for the GlucoTrack model DF-F two years ago, and the same device is in the pre-submission documents filed with the FDA.
The application 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.
Avner Gal, President and CEO of Integrity Applications, 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 U.S. market."
The international law firm of Hogan Lovells is advising the firm with the regulatory and clinical pathway in connection with its seeking FDA approval.
GlucoTrack features a small sensor that clips to the earlobe and measures the wearer's glucose level by taking measurements using three technologies. The measurements are analyzed using a proprietary algorithm and displayed on a small handheld device, the size of a mobile phone.
The derived glucose measurement is also announced verbally, making it suitable for the elderly and vision-impaired diabetes patients.