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FDA clears use of online cognitive/ behavioral assessment to inform ADHD diagnosis


– Pre­vi­ous test (QbTest), which required use of two periph­er­al devices, a small but­ton and a cam­era.

Qbtech receives FDA clear­ance for online test that assess­es ADHD (Mobi­Health News):

Swe­den-based Qbtech has received an FDA 510(k) clear­ance for an online tool, called QbCheck, that offers clin­i­cal deci­sion-mak­ing sup­port for diag­nos­ing and treat­ing chil­dren with ADHD…The test lasts between 15 to 20 min­utes and specif­i­cal­ly mea­sures hyper­ac­tiv­i­ty, impul­siv­i­ty, and inat­ten­tion. QbCheck tests a com­bi­na­tion of sus­tained atten­tion and move­ment analy­sis. Results from the test are com­pared to data from groups of peo­ple, who are the same sex and age, with and with­out ADHD…

Being online means that new cus­tomer groups includ­ing small­er clin­ics, schools, rur­al providers and oth­er qual­i­fied pro­fes­sion­als can pro­vide their patients and clients access to the lat­est med­ical tech­nol­o­gy — a big step to trans­form the man­age­ment of ADHD,” Qbtech CEO Carl Reuter­ski­old said in a state­ment.”

–> FDA pre­mar­ket noti­fi­ca­tion Here. From the fil­ing:

  • Indi­ca­tions for use: QbCheck pro­vides health care pro­fes­sion­als with objec­tive mea­sure­ments of hyper­ac­tiv­i­ty, impul­siv­i­ty, and inat­ten­tion to aid in the clin­i­cal assess­ment of ADHD and in the eval­u­a­tion of treat­ment inter­ven­tions in patients with ADHD. QbCheck results should be inter­pret­ed only by qual­i­fied health care pro­fes­sion­als.
  • Device descrip­tion: QbCheck is a non-inva­sive test that has been devel­oped to pro­vide pre­cise quan­ti­ta­tive assess­ment of the capac­i­ty of an indi­vid­ual to pay atten­tion to visu­al stim­uli and inhib­it impuls­es. There are three car­di­nal dis­tur­bances in Atten­tion-Deficit Hyper­ac­tiv­i­ty Dis­or­der (ADHD); impaired atten­tion, hyper­ac­tiv­i­ty and impul­siv­i­ty. QbCheck pro­vides an accu­rate and repro­ducible mea­sure of an individual’s capac­i­ty in each of these three domains by uti­liz­ing a con­sis­tent chal­lenge par­a­digm cou­pled with detailed real-time mea­sure­ments of behav­ior and per­for­mance. The fun­da­men­tal core of QbCheck is a com­put­er-assist­ed atten­tion and impulse con­trol task and simul­ta­ne­ous record­ing of activ­i­ty. QbCheck is an online solu­tion and no extra hard­ware is need­ed as the test is per­formed on the user’s own com­put­er. For the activ­i­ty track­ing analy­sis QbCheck uses the built in cam­era in the user’s lap­top or a sep­a­rate web cam­era on the user’s desk­top com­put­er.

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