Glucotrack, Inc. (NASDAQ:GCTK) ("Glucotrack" or the "Company"), a medical technology company focused on the design, development, and commercialization of novel technologies for people with diabetes, today announced that it has submitted its Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) to initiate a US clinical study for its fully implantable continuous blood glucose monitoring (CBGM) technology.
The IDE submission represents an important step for Glucotrack and reflects the Company's progress to date in its preclinical development and technical foundation of the technology. With this submission, Glucotrack moves closer to advancing its implantable monitoring system toward clinical evaluation in the United States, with the goal of offering people with diabetes a new option for continuous glucose monitoring designed to provide long-term, real-time, blood-based accuracy without an on-body wearable. The Company plans to proceed with its U.S. clinical study following FDA review and approval.
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