Glucotrack Inc. (NASDAQ: GCTK) announced it has submitted an Investigational Device Exemption application to the U.S. Food and Drug Administration to begin a clinical study of its fully implantable continuous blood glucose monitoring technology.

The medical technology company stated the IDE submission represents progress in its preclinical development work and moves the company closer to clinical evaluation in the United States. The implantable system is designed to monitor glucose levels without requiring an on-body wearable device.

"Submission of our IDE represents meaningful progress in the development of our CBGM technology and underscores our commitment to helping people with diabetes live more fully," said Paul V. Goode, President and Chief Executive Officer of Glucotrack.

The company plans to proceed with its U.S. clinical study following FDA review and approval of the application. According to the press release, the submission follows several years of engineering work, preclinical evaluation, and design development supporting the implantable monitoring system.

Glucotrack's continuous blood glucose monitor is described as a long-term implantable system that measures blood glucose levels with a sensor designed to last three years. The device requires minimal calibration and does not include an on-body wearable component.

The company noted that the Glucotrack CBGM is currently an investigational device limited by federal law to investigational use. The technology is intended to provide continuous glucose monitoring for people with diabetes through blood-based measurements rather than interstitial fluid monitoring used by current wearable devices.