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https://www.accessdata.fda.gov/cdrh_docs/pdf14/K141316.pdfIn case needed. This is the 510K cert

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nidan7500   Wednesday, 03/27/19 04:56:39 PM
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https://www.accessdata.fda.gov/cdrh_docs/pdf14/K141316.pdf

In case needed. This is the 510K cert provided by FDA to Cognision. This product-system has been subsequently identified in the joint patent APP w/AVXL. The recent consortium joined by AVXL w/others (Sage-Merck examples) will apply and expand this type of ERP technology for uses in future AD clinics as described in the patent. This kind of combination product (H/W/-S/W-Pharma) can be complex and expensive to produce in a regulated environment. These are non-trivial technological accomplishments which will present the leadership required for the identification and application of Biomarkers in both trials and in field medical AD outpatient practice.

Note, the PDD trial is now using a form of ERP (Actigraph) specifically designed to monitor and measure and record any patients' sleep data. A giant step for trial protocol.

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