Cerebral Assessment Systems has received marketing approval from the U.S. Food and Drug Administration for Cognivue, a cognitive-assessment tool that functions somewhat like a video game. A patient can perform the inexpensive and simple test while a time-strapped primary-care physician tends to other patients. The 10-minute, noninvasive examination can detect subtle lapses in the brain’s perceptual ability that may signal the early stages of mental decline caused by dementia.
The device received de novo approval from the FDA, a streamlined process for reviewing medical devices that appear to be new enough to have no equivalent and pose little risk.
“I think it’s a really potentially valuable tool,” said Leslie Algase, an internist who tends about 2,000 patients in Rochester, at least 30 percent of whom are older than 65. Algase rates the device as about as accurate as the MMSE. But she said it’s more convenient and less time-consuming to administer.
