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Next: FDA-cleared mobile brain monitoring tools to detect cognitive impairment



FDA Has Cleared New Cog­ni­tive Screen­ing Tests (Alz­fo­rum):

The Food and Drug Admin­is­tra­tion recent­ly cleared, mean­ing it deemed safe, two tests that may help doc­tors screen for cog­ni­tive decline. One is the so-called Cog­ni­sion sys­tem from Neu­ronetrix, a com­pa­ny based in Louisville, Ken­tucky. It is an elec­troen­cephalog­ra­phy (EEG) device that allows non-spe­cial­ists to mea­sure elec­tri­cal activ­i­ty in the brain with a portable, hand-held recorder…The oth­er is a cog­ni­tive assess­ment bat­tery that can be admin­is­tered on a mobile device, such as a smart­phone or tablet. Called the Defense Auto­mat­ed Neu­robe­hav­ioral Assess­ment (DANA) and devel­oped by Anthro­Tron­ix in Sil­ver Spring, Mary­land, this set of tests mea­sures items like reac­tion time, spa­tial dis­crim­i­na­tion, and mem­o­ry…

The Patient Afford­able Care Act of 2010 requires that Medicare pay for an annu­al well­ness visit—including a test for cog­ni­tive impair­ment. Because the Cen­ters for Medicare and Med­ic­aid Ser­vices has not iden­ti­fied spe­cif­ic tests for reim­burse­ment, pri­ma­ry care physi­cians are left to choose. Guide­lines for­mu­lat­ed by an expert pan­el con­vened by the Alzheimer’s Asso­ci­a­tion rec­om­mend sev­er­al quick tests, includ­ing the AD8, the Gen­er­al Prac­ti­tion­er Assess­ment of Cog­ni­tion, and the Mem­o­ry Impair­ment Screen, but they did not eval­u­ate DANA…”

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