Glucotrack to file IDE with FDA for implantable CBGM in Q2 2026, citing positive trial results

Glucotrack, Inc.

Brazil first-in-human study (Dec 2024-Jan 2025) showed MARD 7.7%, 99% data capture, and zero serious adverse events.
Australia feasibility study started July 2025; findings are incorporated for planned US trial.
Three US patents issued Oct/Nov 2025 covering sensor chemistry, intravascular lead, and low-power electronics.
Expects to file IDE with FDA in Q2 2026 and initiate US clinical study in H2 2026, pending approval.
Reinforced commercial foundation: market research, reimbursement pathway, dual-source manufacturing, seasoned leadership.

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