Sinaptica Therapeutics announced today that it received FDA breakthrough device designation for its investigational SinaptiStim AD system.
Cambridge, Massachusetts-based Sinaptica designed its system to treat cognitive and functional decline in patients diagnosed with Alzheimer’s disease (AD).
The system creates a novel integration of neurostimulation and brain wave monitoring technologies. It combines those with a proprietary AI-derived personalization engine. Sinaptica said in a news release that SinaptiStim represents a new approach to treating patients suffering from dementia.
Under the FDA breakthrough program, Sinaptia receives priority regulatory review. The company can also maintain interactive communication with the FDA throughout the premarket review phase.
“Groundbreaking potential”“We are excited that the FDA has recognized the groundbreaking potential of our SinaptiStim AD system with Breakthrough Device Designation,” sai…