The Food and Drug Administration on Monday for the first time gave a green light to a game-based therapeutic: a video game meant to be prescribed to kids with ADHD.
The game, known as EndeavorRx and developed by Boston-based Akili Interactive Labs, can now be marketed as a way to improve attention function in kids with ADHD as measured by computerized testing. Physicians can prescribe it to children between the ages of 8 and 12 who have an ADHD diagnosis and have demonstrated an issue with attention.
The FDA’s move is a landmark decision in the emerging digital therapeutics sector: In addition to being the first game to be marketed as a therapy for any type of condition, EndeavorRx is the first digital therapeutic meant to improve symptoms associated with ADHD, the FDA’s announcement said…The game was born in the University of California, San Francisco lab of neuroscientist Adam Gazzaley, and was licensed out by Akili, which polished and tested the game in clinical trials. Akili spent the past two years waiting on a regulatory decision from the FDA.
Happy to share that Dr. Lathan, CEO of AnthroTronix, will discuss the brand-new 510(k) FDA clearance of their DANA neurocognitive test at the 2014 SharpBrains Virtual Summit (October 28–30th), during the session Best practices to assess and enhance brain function via mobile devices and wearables.
Dr. Corinna Lathan leads AnthroTronix, a biomedical engineering product development company and pioneer in mobile platform technology. Their DANA™ product is [Read more…] about AnthroTronix CEO Corinna Lathan to discuss 510(k) FDA clearance of its DANA neurocognitive test at 2014 SharpBrains Virtual Summit