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FDA Asks Glucose Monitor Hackers For Gap Analysis Report

This article was originally published in The Gray Sheet

Executive Summary

Citizen device hacking group NightScout says the agency wants to allow them to continue their work but wants to see a report on measures to log and report any user confusion, technical problems or adverse events and meet again in three months to discuss. The group, which modifies DexCom glucose receivers to track real time data over the internet, met with FDA Oct. 8.

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