/Glucotrack Announces IDE Submission for U.S. Clinical Study of its Novel Implantable Continuous Blood Glucose Monitoring Technology
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Glucotrack Announces IDE Submission for U.S. Clinical Study of its Novel Implantable Continuous Blood Glucose Monitoring Technology

GlobeNewswire
2026/05/07Clinical Study

Glucotrack Announces IDE Submission for U.S. Clinical Study of its Novel Implantable Continuous Blood Glucose Monitoring Technology

RUTHERFORD, N.J., May 07, 2026 — 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.

“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, PhD, President and Chief Executive Officer of Glucotrack. “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 socialize 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.”

The IDE submission follows several years of focused engineering, preclinical evaluation, and iterative design work supporting the development of a long‑term, fully implantable CBGM system. Data generated to date support advancing the technology into U.S. clinical evaluation as the Company enters the next phase of development.

For more information about Glucotrack's CBGM, visit www.glucotrack.com.

About Glucotrack, Inc.

Glucotrack, Inc. (NASDAQ: GCTK) is focused on the design, development, and commercialization of novel technologies for people with diabetes. The Company is currently developing a long-term implantable continuous blood glucose monitoring system for people living with diabetes.

Glucotrack’s Continuous Blood Glucose Monitor (CBGM) is a long-term, implantable system that continually measures blood glucose levels with a sensor longevity of 3 years, no on-body wearable component and with minimal calibration. The Glucotrack CBGM is an Investigational Device and is limited by federal (or United States) law to investigational use.

For more information, please visit http://www.glucotrack.com. Information on the Company’s website does not constitute a part of and is not incorporated by reference into this press release.

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Summary

Submission supports advancement of a long‑term, fully implantable, blood‑based continuous glucose monitoring platform Submission supports advancement of a long‑term, fully implantable, blood‑based continuous glucose monitoring platform