Pathdoc
Member
Registered: Feb 2001
Location: Minnesota
Posts: 216 |
Re: Here's a glucose meter!
quote: Originally posted by Ruprect
Here's one in development. It's made by Therasense.
The bummer is that, because it's a medical product, the FDA or the AMA hasn't approved it. That process could take years. :-(
AMA would have nothing to do with it. The FDA, on the other hand, would have to approve it. The problem there would not be approving the module as I am sure that it works off of the same chemitries and senosrs that all glucose monitors work on, but rather the FDA approving the VISOR HANDHELD and the SOFTWARE! I am betting the FDA would want clearance of the Visor as a medical device (referred to as 510K clearance) which would require a lot of work on the part of HandSpring. Similarly, any program to collect and use the data would have to be approved as well.
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