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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