Cambridge Cognition Holdings PLC has announced it has received 510(k) clearance from the U.S. Food and Drug Administration (‘FDA’) to market its CANTAB Mobile product as a medical device. CANTAB Mobile is designed to detect clinically-relevant memory impairment in older adults at the point of care. It includes a computerized 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 touchscreen test, which takes under 10 minutes to complete, can be self-administered using voiceover instructions in over 20 languages with automatic scoring, accounting for age, gender and education level. All results can be accessed in a simple to interpret, one-page physician’s report using a traffic-light output for memory and mood outputs. The 510(k) clearance for CANTAB Mobile allows company to market the medical device for commercial distribution in the U.S. where significant interest in the product has developed among primary and secondary care organizations and corporate health providers.