Sinaptica’s SinaptiStim – AD Systems Receives Breakthrough Device Status
The FDA has granted Sinaptica Therapeutics a Breakthrough Device designation for its SinaptiStim – AD System, an electromagnetic therapy for cognitive and functional decline in Alzheimer’s disease patients.
The device integrates neurostimulation and brain wave monitoring technologies with a proprietary artificial intelligence-based tool to deliver personalized non-invasive electromagnetic therapy.
The therapy targets the dysregulation of brain networks seen in Alzheimer’s patients, restoring normal network activity and connectivity, thereby improving cognitive function, the company said.
Sinaptica says it hopes to initiate a trial sometime next year.
The goal of the Breakthrough Devices Program is to expedite the development of devices that offer more effective treatment of life-threatening or debilitating diseases or conditions.