Cognito Therapeutics’ Treatment For Alzheimer’s Receives FDA Breakthrough Designation
On January 12, 2021, Cognito Therapeutics announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to its digital therapeutic device to treat memory and cognitive problems due to Alzheimer’s disease. The device, GammaSense stimulation system, provides non-invasive neurostimulation using gamma frequency technology. It is not yet commercially available. The Breakthrough Designation gives the company priority review and additional opportunities to work with FDA officials through clinical and commercial development.
The GammaSense stimulation system is built into a pair of opaque glasses worn with a set of headphones. It uses specific frequencies of flashing . . .