Cambridge Cognition announces 510(k) clearance from the FDA to market CANTAB Mobile as a medical device designed to detect clinically-relevant memory impairment.

Cambridge Cognition announces it has received 510(k) clearance from the FDA to market CANTAB Mobile as a medical device in the U.S. CANTAB Mobile is designed to detect clinically-relevant memory impairment in older adults at the point of care.

It includes a computerised test of visuospatial associative learning (CANTAB PAL) to assess episodic memory with optional mood and functional assessments, which can help to detect symptoms of depression and problems with performing regular activities of daily living.

The objective touchscreen test takes into consideration the age, gender and education of the patient to provide an instant and accurate report so that they can receive timely reassurance or referral in a single visit. The CANTAB Mobile assessment combines a specific memory test, which has been used in clinical research of Alzheimer's disease for over 30 years, with a depression screen to differentiate symptoms .

Comment: Cambridge Cognition has designed the device, CANTAB Mobile, to help physicians detect early signs of clinically relevant memory impairment. The device is based on the well-established Paired Associates Learning (PAL) test, which was developed to assess episodic memory without language barriers.

Comment: Cambridge Cognition secured medical device status for CANTAB Mobile in Europe in 2013. Since then, it has been used to assess the episodic memory of 26,000 patients in the United Kingdom.