StockWatch
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Medical/Dental Instruments
USFDAMay 7, 2026, 01:02 PM

Glucotrack Submits FDA IDE for Implantable CBGM Clinical Study

AI Summary

Glucotrack, Inc. announced the submission of its Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) for its fully implantable continuous blood glucose monitoring (CBGM) technology. This represents a significant step towards initiating a US clinical study for the device, which aims to provide long-term, real-time, blood-based glucose accuracy without an on-body wearable. The company plans to advance its implantable monitoring system into clinical evaluation in the United States following FDA review and approval, offering a discreet and comfortable solution for people with diabetes.

Key Highlights

  • Glucotrack submitted an Investigational Device Exemption (IDE) application to the U.S. FDA.
  • The IDE is for its fully implantable continuous blood glucose monitoring (CBGM) technology.
  • The submission aims to initiate a US clinical study for the device.
  • The CBGM is designed for long-term, real-time, blood-based accuracy without an on-body wearable.
  • The implantable system is intended to have a sensor longevity of 3 years with minimal calibration.
  • Glucotrack plans to proceed with the U.S. clinical study following FDA review and approval.