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.
According to the company, the normal route for diagnosing ADHD is complicated, involves, administrative costs, and carries risk for bias. Qbtech’s process aims to make ADHD easier to identify, rule out, and monitor.
The company already offers a similar test, called QbTest, which is a computer-based diagnostic test that makes use of two peripheral devices, a small button and a camera. This version has been performed by about 250,000 patients in Europe and the US.
QbCheck is similar to QbTest, except it’s all online and makes use the space bar instead of a button, and the computer’s web camera instead of a standalone camera. 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.
Qbtech Commercial Director Tony Doyle said in a statement that this month, the offering would launch in UK, followed by other countries in the summer and in the fall.
Earlier this year, the CEO of Akili Interactive Labs, which is developing video game intervention to treat ADHD, told MobiHealthNews that they plan to receive FDA clearance and bring the product to market by the end of 2017. At the time, Akili had raised $30.5 million.