News Reports

FDA Clears New Version of Electronic ADHD Assessment Aid

The ninth version of the Test of Variables and Attention, known as TOVA, was recently cleared by the FDA as an aid in the assessment of attention disorders.

January 16, 2018

The Food and Drug Administration (FDA) has cleared version 9 of TOVA, the Test of Variables and Attention developed to measure attention and inhibitory control. Since TOVA’s inception, clinicians and researchers have used this computer-based tool to assess attention disorders, including ADHD, the TOVA Company said in a statement.

TOVA uses both auditory and visual stimuli to measure inattention and impulsivity. According to the company’s website, the test is divided into two parts: in the first, subjects must maintain attention and respond to infrequent targets; in the second, they must inhibit themselves from responding to more frequent targets.

The latest version has been updated to address timing delays in computers that can affect results, the company said in its press release. It also “features embedded performance validity to flag unusual performance.”

Any company seeking to market medical devices in the United States must pass a review process with the FDA through one of two pathways: the Premarket Approval (PMA) process, where a device is “approved” by the FDA, or the section 510(k) process, where a device is “cleared” for distribution if an equivalent device is already on the market.

More information about TOVA can be found on the company’s website. Documents related to the FDA’s decision can be accessed online.

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