Australia’s Omniscient Gets 510(k) Clearance for Digital Brain Mapping Platform

July 26, 2021

Omniscient Neurotechnology has received 510(k) clearance from the FDA for Quicktome, a digital brain-mapping platform for neurosurgery.

The software, which is intended to help neurosurgeons visualize a patient's brain networks before performing brain surgery, uses connectomics — the study and mapping of the brain's structural and functional connections between cells.

By visualizing the networks responsible for complex functions, such as language, movement and cognition, the software “assists neurosurgeons in making more informed decisions and reduces surgical uncertainty,” the company said.

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