Cerebral Assessment Systems Snags De Novo Approval For Cognivue

Cerebral Assessment Systems’ Cognivue cognition assessment aid has secured FDA de novo approval, the Pittsford, N.Y., devicemaker announced Thursday.

The computer-based device is able to assess, measure and monitor neurological function to detect early signs of cognitive decline indicative of later-life dementia, the company says. The noninvasive assessment can be administered in an exam room or primary care office, taking about 10 minutes and only requiring the person being tested to grasp the device.

Given the product’s de novo status, the FDA has created a new medical device classification called Cognitive Assessment Aids.

Cerebral Assessment Systems received National Institute of Health funding during the device’s development stage. — Jason Scott