Glucotrack has submitted an investigational device exemption (IDE) application to the US Food and Drug Administration (FDA), seeking approval to begin a clinical study in the US for its continuous blood glucose monitoring (CBGM) technology.
The IDE submission marks a significant milestone in advancing the company’s fully implantable monitoring system to the next stage of clinical assessment, pending FDA review and approval.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The technology aims to offer an option for ongoing blood glucose measurement.
This implantable device is designed to deliver real-time, blood-based data without requiring an on-body wearable, and the company believes it may address certain needs for people with diabetes during daily activities.
Before this submission, the company’s work included engineering validation, preclinical research, and refinement of the device design to support its progression to clinical testing.
Glucotrack president and CEO Paul Goode said: “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.
“Our fully implantable solution is designed to be comfortable and discreet so that people can focus on their daily lives – allowing them to work, exercise, sleep, and socialise without the disruption of frequent sensor changes, visible wearables, or reordering supplies.
“We look forward to generating the clinical data needed to advance toward regulatory approval and demonstrate that continuous glucose monitoring can be both highly accurate and virtually invisible.”
In May 2025, Glucotrack announced the receipt of St Vincent’s Hospital Melbourne Human Research Ethics Committee’s (HREC) approval for a multi-centre clinical study of its continuous blood glucose monitor (CBGM) in type 1 and type 2 diabetic patients.
