The SinaptiStim™ - AD System (AD) was developed by Sinaptica Therapeutics to treat Alzheimer's patients who are losing cognitive and functional abilities.
The system is a novel integration for treating dementia patients that combines neurostimulation and brain wave monitoring technologies with a proprietary personalization engine created by artificial intelligence (AI).
The FDA's Breakthrough Devices Program seeks to provide patients and healthcare professionals with timely access to new technologies by accelerating the development, assessment, and review of medical devices that provide more effective treatment of life-threatening or irreversibly debilitating diseases or conditions than existing approved or cleared therapies.
Under the programme, Sinaptica will receive a priority evaluation and frequent communication from the FDA during the premarket review stage.
