On March 27, 2026, Glucotrack, Inc. (NASDAQ: GCTK), a medical technology company focused on diabetes management, announced its intention to file an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration (FDA) for its innovative continuous blood glucose monitoring (CBGM) technology. This decision follows significant operational milestones achieved in 2025, including the completion of a first-in-human clinical trial in Brazil and the initiation of a follow-up study in Australia. The company aims to submit the necessary documentation to the FDA during the second quarter of 2026.

CEO Paul V. Goode highlighted the progress made in developing the fully implantable CBGM technology, which is designed to provide accurate blood glucose measurements without the lag time associated with traditional continuous glucose monitoring systems. The Brazilian trial demonstrated excellent accuracy with a Mean Absolute Relative Difference (MARD) of 7.7% across 122 matched pairs, and a 99% data capture rate, with no serious adverse events reported.

In addition to clinical advancements, Glucotrack has conducted extensive market research indicating a strong demand for its technology among diabetes patients and healthcare providers. The company has also established a clear reimbursement pathway and secured partnerships with qualified contract manufacturers to support its U.S. clinical trial program. With these foundational elements in place, Glucotrack is poised to initiate its U.S. clinical study in the latter half of 2026, pending FDA approval of its IDE submission.

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