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The FDA clears two computerized cognitive tests to assist in medical evaluations following brain injury or concussion

impact testingFDA allows mar­ket­ing of first-of-kind com­put­er­ized cog­ni­tive tests to help assess cog­ni­tive skills after a head injury (FDA news release):

The U.S. Food and Drug Admin­is­tra­tion today per­mit­ted mar­ket­ing of two new devices to assess a patient’s cog­ni­tive func­tion imme­di­ate­ly after a sus­pect­ed brain injury or con­cus­sion. The Imme­di­ate Post-Con­cus­sion Assess­ment and Cog­ni­tive Test­ing (ImPACT) and ImPACT Pedi­atric are the first med­ical devices per­mit­ted for mar­ket­ing that are intend­ed to assess cog­ni­tive func­tion fol­low­ing a pos­si­ble con­cus­sion. They are intend­ed as part of the med­ical eval­u­a­tion that doc­tors per­form to assess signs and symp­toms of a head injury…

ImPACT soft­ware runs on a desk­top or lap­top and is intend­ed for those ages 12 to 59, while the ImPACT Pedi­atric runs on an iPad and is designed for chil­dren ages 5 to 11. Only licensed health care pro­fes­sion­als should per­form the test analy­sis and inter­pret the results.

Trau­mat­ic brain injuries account for more than 2 mil­lion emer­gency room vis­its in the Unit­ed States each year, accord­ing to the U.S. Cen­ters for Dis­ease Con­trol and Pre­ven­tion, and con­tribute to the deaths of more than 50,000 Amer­i­cans…

The man­u­fac­tur­er sub­mit­ted over 250 peer-reviewed arti­cles, of which half were inde­pen­dent­ly con­duct­ed clin­i­cal research studies…The FDA con­clud­ed that these stud­ies pro­vide valid sci­en­tif­ic evi­dence to sup­port the safe­ty and effec­tive­ness of the ImPACT and ImPACT Pedi­atric devices.

The FDA reviewed the ImPACT device through its de novo clas­si­fi­ca­tion process, a reg­u­la­to­ry path­way for nov­el, low- to-mod­er­ate-risk med­ical devices that are first-of-a-kind, for which spe­cial con­trols can be devel­oped, in addi­tion to gen­er­al con­trols, to pro­vide a rea­son­able assur­ance of safe­ty and effec­tive­ness of the devices.”

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