SI
SI
discoversearch

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : Rosetta Genomics (ROSG) - microRNA -- Ignore unavailable to you. Want to Upgrade?


To: Steve Lokness who wrote (37)1/18/2009 12:41:20 PM
From: tuck  Read Replies (3) | Respond to of 58
 
By trials in humans, I mean a controlled and blinded trial. See also this:

fda.gov

Jim or idos may know better, since I don't follow the dx companies very closely anymore (maybe I should renew my acquaintance), but I think this guidance is pretty much law now. I would guess that this dx would be a Class II device as described in there.

Cheers, Tuck