Cambridge Cognition gains US regulatory approval for memory test

Neuroscience digital health company Cambridge Cognition has gained regulatory clearance for its memory test to be used as a medical device in the US.

Cantab Mobile, which detects clinically-relevant memory impairment in older adults at the point of care, received 510k clearance for the US Food and Drug Administration to be marketed a medical device.

The 510k clearance means that the company can market the medical device for commercial distribution in the US.

Cantab Mobile assesses memory with optional mood and functional tests, which can help to detect symptoms of depression and problems with performing daily activities.

The touchscreen test, which takes under 10 minutes to complete, can be self-administered using voiceover instructions in over 20 languages with scoring that accounts for age, gender and education.

The device, which is based on 30 years of research into Alzheimer's disease and over 500 peer-reviewed papers, gained European regulatory approval in 2013 and has since been used to assess over 26,000 patients in the UK who had concerns about their memory or were at increased risk of dementia.

Chief executive Dr Steven Powell, 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 510k clearance. Access to the large US healthcare market combined with the recent investment in our US operation will help underpin the company's revenues and its continued growth."

Shares in Cambridge Cognition were up 16.31% to 82p at 0831 GMT.