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FDA approves Pittsford firm's Cognivue device

Rochester Business Journal
June 8, 2015

The Food and Drug Administration has greenlighted Cerebral Assessment Systems Inc.’s Cognivue device for U.S. distribution.

The approval clears the way for the Pittsford firm to start large-scale production and marketing of the device, CAS officials said.

A computer-based system that with an easily administered, non-invasive 10-minute test measures an individual’s cognitive functioning, the device for the first time offers primary care physicians a chance to catch cognitive decline at its earliest stage.

Lack of a reliable test to detect dementias such as Alzheimer’s disease before they start severely compromising patients’ mental abilities has long frustrated researchers and clinicians.

Drugs that might help early-stage dementia patient slow or halt cognitive decline’s progress have proven to be of only moderate benefit to later stage sufferers.

A way to more reliably measure cognitive functioning would help researchers also, providing a way to better evaluate treatments in clinical trials.  

Cognivue tests do not specifically diagnose Alzheimer’s disease or any other dementia. But by yielding a number that quantifies the efficiency of a test subject’s cognitive functions, they can detect the beginnings of decline well before more obvious dementia symptoms arise.

An indication of that capability’s novelty: To approve the Cognivue, the FDA created a brand new medical device category—cognitive assessment aids.

Prior to getting the agency’s go-ahead to market the device, CAS had lined up a contract manufacturer and had been in talks with several medical device companies over a possible partnership to market and distribute Cognivue. 

CAS is contacting interested primary care practices and plans to start shipping units this fall, CEO Charles Duffy M.D. said. 

FDA approval would heighten device makers’ interest in the device, CAS director Jay Birnbaum told the Rochester Business Journal in a recent interview

Currently approved for reimbursement the Centers for Medicare and Medicaid Service’s northeast region, the device would become standard equipment in most U.S. primary care offices if other CMS regions follow suit, Duffy predicted.

For more on CAS’ plans, see the June 5 edition of the Rochester Business Journal

(c) 2015 Rochester Business Journal. To obtain permission to reprint this article, call 585-546-8303 or e-mail

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