Abbott/TheraSense FDA panel rescheduled
This article was originally published in The Gray Sheet
Diabetes test manufacturer is working with FDA to establish a panel date for the FreeStyle Navigator continuous glucose monitor system, which uses interstitial fluid, after the agency mistakenly issued and then retracted a notice that its Clinical Chemistry & Clinical Toxicology Devices Panel would review the device on Oct. 13. TheraSense submitted a PMA last November. Upon approval, FreeStyle will compete with Medtronic's Guardian CGMS. Roche/Disetronic is developing similar technology...
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