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Cognetivity Neurosciences Gets FDA’s 510(k) Clearance for Cognitive Assessment

October 25, 2021

Cognetivity Neurosciences has received 510(k) clearance from the FDA for its CognICA integrated cognitive assessment.

The computerized test for early-stage cognitive impairment can support large-scale, remote, self-administered testing and is intended to be integrated with existing electronic health record systems, the company said.

The five-minute cognitive assessment, which is delivered on iPad devices, has already received a CE mark certification.

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