Digital health company Cambridge Cognition has received regulatory clearance from the FDA to market its memory impairment device as a medical device.
Cambridge Cognition’s Cantab Mobile product, is a cognitive assessment designed to detect clinically-relevant memory impairment. The app uses a touchscreen test to help detect symptoms of depression and alzheimer’s. The test uses visuospatial associative learning to assess episodic memory, and includes optional mood and functional assessments.
The test can be self-administered and includes a scoring system that accounts for age, gender and education. Users can access results through an easy to read physician’s report which uses a traffic-light system to identify memory and mood performance.
Cantab Mobile is already classified as a medical device but this latest regulatory approval lets the company commercially market the product. The product has been used to assess over 26,000 patients in the UK who had concerns about their memory, or were considered by their physicians to be at increased risk of dementia.
Dr Steven Powell, chief executive officer, Cambridge Cognition, said: “There is a great unmet need for effective near patient assessment tools to assess memory impairment. CANTAB Mobile is an established and proven digital health product and we are delighted to announce the 510(k) clearance. Access to the large US healthcare market combined with the recent investment in our U.S. operation will strengthen the Company’s revenue and continued growth.”