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FDA grants 501(k) clearance to mobile memory test
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Cambridge Cognition recently announced the FDA granted 501(k) clearance to market CANTAB Mobile, a computerized test of visuospatial associative learning, as a medical device in the US.
“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,” Steven Powell, PhD, CEO of Cambridge Cognition, said in a press release. “Access to the large U.S. healthcare market combined with the recent investment in our U.S. operation will help underpin the company’s revenues and its continued growth.”
CANTAB Mobile is a touchscreen test intended to detect clinically relevant memory impairment in older adults. The test assesses episodic memory and features optional mood and functional assessments to indicate symptoms of depression or problems affecting daily living activities.
The test takes approximately 10 minutes to complete and can be self-administered with voiceover instructions in more than 20 languages.
Results can be processed into a simple one-page physician’s report that uses a traffic light to indicate memory and mood outcomes.
CANTAB Mobile has been used among more than 26,000 individuals in the United Kingdom since its classification as a European Mobile Device in 2013, according to the release.
The test was developed using more than 30 years of Alzheimer’s disease research and 500 peer-reviewed studies.