The Washington Post (8/11, Kunkle) reports that the Food and Drug Administration gave de novo marketing approval to Cerebral Assessment Systems’ Cognivue, “a cognitive-assessment tool that functions somewhat like a video game” and “can detect subtle lapses in the brain’s perceptual ability that may signal the early stages of mental decline caused by dementia.” The device is for medical professional use only and “is not intended to be a standalone diagnostic tool.”
Related Links:
— “FDA approves tool for diagnosing dementia in a doctor’s office,” Fredrick Kunkle, Washington Post, August 10, 2015.