Business
Glucotrack to File Significant IDE with FDA for US Clinical Trial in Early Q2 Based on Critical 2025 Milestones
Experience From Brazilian and Australian Clinical Trials Positions the Company to Submit Investigational Device Exemption (IDE) to FDA for Novel CBGM
About this update from Glucotrack, Inc.
[{"type":"text","content":"Experience From Brazilian and Australian Clinical Trials Positions the Company to Submit Investigational Device Exemption (IDE) to FDA for Novel CBGM Technology in Q2 2026\nRUTHERFORD, N.J., March 27, 2026 (GLOBE NEWSWIRE) -- 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 provided a comprehensive recap of the critical operational milestones which have positioned the Company to submit an IDE to the U.S. Food and Drug Administration (FDA) for its novel continuous blood glucose monitoring (CBGM) technology, with a goal to file requisite documents with the FDA during Q2 of 2026. “In 2025 we made meaningful progress in advancing the development of our fully implantable continuous blood glucose monitoring technology and strengthening Glucotrack’s foundation,” commented Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack. “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,” Dr. Goode added. “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 te...