De Novo
The company was also the first to receive emergency use authorization for its home COVID-19 test in 2021.
The tool uses virtual reality to modify media content in order to help children boost their visual acuity.
The eXciteOSA strengthens tongue muscles through electrical stimulation, and comes with a companion app for tracking and sharing progress.
The company said that its tool was "highly accurate" in a 425-participant study conducted across 14 U.S. sites.
The long-awaited decision is the first regulatory authorization for Akili, and the first game-based therapeutic that the FDA has greenlit for any condition.
Caption Health's tool instructs non-expert medical staff on how best to produce high-quality diagnostic images in real time.