GlucoTrack files FDA IDE in Q2 2026; first-in-human CBGM study posts 7.7% MARD

Reuters03-27 20:03

GlucoTrack files FDA IDE in <a href="https://laohu8.com/S/QTWO">Q2</a> 2026; first-in-human CBGM study posts 7.7% MARD

GlucoTrack said it plans to submit an investigational device exemption $(IDE)$ to the FDA in Q2 2026 for a US clinical trial of its implantable continuous blood glucose monitoring technology.
It reported results from a first-in-human, 5-day in-hospital study in Brazil with 10 participants, where the trial met primary and secondary endpoints.
Reported performance metrics from the Brazil study included a mean absolute relative difference (MARD) of 7.7% and a 99% data capture rate.
The company also said it initiated a feasibility clinical trial in Australia in July 2025 and used learnings from that study to update the protocol and product design.
GlucoTrack expects the US study could begin in the second half of 2026, pending FDA approval of the IDE submission.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. GlucoTrack Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202603270801PRIMZONEFULLFEED9679582) on March 27, 2026, and is solely responsible for the information contained therein.

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