Glucotrack (Nasdaq:GCTK) today provided an update on the planned regulatory timeline for its continuous blood glucose monitor (CBGM).
The Glucotrack device features no on-body external component. The company designed it for three years of continuous, accurate blood glucose monitoring for a more convenient, less intrusive solution. Unlike traditional CGMs that measure glucose in interstitial fluid, the CBGM measures glucose levels directly from the blood. It aims to provide real-time readings without the lag time typically associated with interstitial glucose measurements.
Glucotrack Chief Science Officer Mark Tapsak outlined how the system works at the American Diabetes Association’s (ADA) 85th Scientific Sessions in Chicago in June.
Rutherford, New Jersey-based Glucotrack plans to submit its CBGM for FDA investigational device exemption (IDE) during the second quarter of 2026. This aligns with previously announced plans after the company announced a slight delay to its timeline last November.
The company recently secured new patents for its CBGM, protecting key technologies, including proprietary sensor chemistry, intravascular lead design and low-power electronics. It said the innovations bridge the gap between short-use subcutaneous sensors, like those from Abbott and Dexcom, and larger, pacemaker-class devices.
Commentary from Glucotrack President and CEO Paul V. Goode
“In 2025 we made meaningful progress in advancing the development of our fully implantable continuous blood glucose monitoring technology and strengthening Glucotrack’s foundation. The completion of our first‑in‑human study in Brazil and initiation of our follow up study in Australia enables us to advance toward our U.S. clinical program. With trial infrastructure in place and product enhancements completed, we are prepared to initiate the study, pending FDA approval.”
“In parallel, we have continued to strengthen the commercial and operational foundation of the business. We have completed extensive U.S. market research across patients and multiple healthcare provider segments, which indicates an unmet need for a fully implantable CBGM solution. Diabetes represents one of the largest addressable healthcare markets globally, with continuous glucose monitor (CGM) among its fastest‑growing and most dynamic segments. Our research indicates that our differentiated technology has the potential to deliver meaningful, scalable impact for millions of patients.”
“We have also identified a clear U.S. reimbursement pathway that supports a compelling economic profile, built a dual‑source U.S. manufacturing strategy with two qualified contract manufacturing partners, and assembled a seasoned management team with deep experience in diabetes and implantable medical technologies from industry leaders such as Dexcom, Abbott, Senseonics, and Medtronic.”
“We are extremely proud of the accomplishments we achieved as a team in 2025, and we are prepared to execute further on the development of our first-to-market CBGM system to meet the needs of the millions of people living with diabetes in the U.S. alone.”
