FDA Hits Pearson With Warning Over ADHD Device Claims
The FDA published a warning letter it sent to NSC Pearson over issues with the company’s Quotient ADHD being marketed as a consumer device to treat ADHD without the proper clearance.
Pearson’s system, originally named the OPTAx system, was cleared with indications for use “as a device that provides clinicians with objective measurements of hyperactivity, impulsivity and inattention to aid in the clinical assessment of ADHD,” according to the federal watchdog.
The Quotient system is a device that measures 3 indicators of ADHD, according to the company’s site, which calls it an “easy-to-administer tool” that “uses advanced motion tracking technology to track a child or adult’s micromovements while they complete a 15-20 minute computerized test.”
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Pearson’s system, originally named the OPTAx system, was cleared with indications for use “as a device that provides clinicians with objective measurements of hyperactivity, impulsivity and inattention to aid in the clinical assessment of ADHD,” according to the federal watchdog.
The Quotient system is a device that measures 3 indicators of ADHD, according to the company’s site, which calls it an “easy-to-administer tool” that “uses advanced motion tracking technology to track a child or adult’s micromovements while they complete a 15-20 minute computerized test.”
Help employers find you! Check out all the jobs and post your resume.