Anavex Life Sciences Corp (AVXL)

[nidan7500]

SCORE: see Cognision system w/AI and FDA 510K K141316
#issued...good information to have as we go forward here. This should indicate some evaluation of the overall system has been conducted and found to be safe and effective. We do not yet know if any validation of claims for medical device uses in AD clinical uses, but would guess that would be the very first thing Dr.M. would ask.(anyone know how to get copy of FDA product test investigation w/o FOIA?) More evaluation before the use of the system as biomarker source for AD. DO NOT KNOW THAT YET, BUT THE POSSIBILITY SUGGESTS ITSELF. Could be a very NICE piece of technology for our purposes. This might also splain a few things.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K141316

Keep digging everyone, there's a pony in here somewhere.

Device Classification Name
non-normalizing quantitative electroencephalograph software
510(k) Number
K141316
Device Name
COGNISION EEG/EP SYSTEM
Applicant
NEURONETRIX SOLUTIONS
816 CONGRESS AVENUE, SUITE 1400
austin, TX 78701
Applicant Contact
cheryl fisher
Correspondent
NEURONETRIX SOLUTIONS
816 CONGRESS AVENUE, SUITE 1400
austin, TX 78701
Correspondent Contact
cheryl fisher
Regulation Number
882.1400
Classification Product Code
OLT
Subsequent Product Codes
GWJ
OMC
Date Received
05/20/2014
Decision Date
02/13/2015
Decision
substantially equivalent (SESE)
Regulation Medical Specialty
Neurology
510k Review Panel
Neurology
summary
summary
Type
Traditional
Reviewed by Third Party
No
Combination Product
No