The FDA has cleared Cambridge Cognition to market its touchscreen memory impairment test. The 510(k) nod allows Cambridge Cognition to start marketing the 10-minute, self-administered test as a way to assess the memories of patients who are at increased risk of dementia.
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.
Building on this science, Cambridge Cognition created a touchscreen screening tool that delivers three tests to measure memory, mood and ability to perform daily activities. The test asks the user questions such as “are you in good spirits most of the time?” and “in the past three months, were you able to keep track of current events in the news or media?”
By comparing the answers to data from people of the same age, gender and level of education, the device generates a one-page report detailing whether the patient’s memory and mood need monitoring or are not currently a concern.
Cambridge Cognition thinks there is value in giving physicians access to such reports.
“There is a great unmet need for effective near patient assessment tools to assess memory impairment,” Cambridge Cognition CEO Steven Powell said in a statement.
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. Now, CANTAB Mobile is set to come to the U.S., a market in which Cambridge Cognition claims there is “significant interest in the product ... among primary and secondary care organizations and corporate health providers.”
In anticipation of securing clearance to sell CANTAB Mobile to these groups, Cambridge Cognition raised cash last year and used it to restructure its sales infrastructure in the U.S.. With these preparations in place, the company thinks the 510(k) clearance gives it a notable opportunity.
“Access to the large U.S. healthcare market combined with the recent investment in our U.S. operation will strengthen the company’s revenue and continued growth,” Powell said.
Shares in Cambridge Cognition rose 5% in London on the back of the news.