The EndeavorRx, which uses computer-based testing to measure improvements in attention function and is intended to be use as “part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs,” is the first game-based therapeutic device to gain FDA-approval for this or any other indication, the agency noted in a news release.
’The EndeavorRx device offers a non-drug option for improving symptoms associated with ADHD in children and is an important example of the growing field of digital therapy and digital therapeutics,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics.”
This approval was based on results from multiple studies involving over 600 kids, “including studies that evaluated, among other things, whether participants demonstrated improvements in attention function, as measured by the Test of Variables of Attention (TOVA), academic performance measures, and other assessment tools,” the FDA wrote. “There were no serious adverse events reported. The most common adverse events observed with EndeavorRx are: frustration, headache, dizziness, emotional reaction, and aggression.”
The FDA reviewed this device using the De Novo premarket review pathway, which allows for future devices similar to the EndeavorRx intended for the same use to go through the 510(k) premarket notification process and obtain marketing authorization by proving sufficiently similar to the original device.
The EndeavorRx is manufactured by Akili Interactive.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 136
Topic ID: 85,136,730,136,192,53