Intravent Nabs 510(k) Clearance for ‘Neuro-Navigation’ Device

September 15, 2021

Intravent Medical Partners has received the FDA’s 510(k) clearance for its Solopass “neuro-navigation” system.

Solopass is designed to provide imaging and guidance to improve the placement of external ventricular drains, one of the most common procedures in neurointensive care.

The imaging system is designed to help neurosurgeons navigate when the anatomy within the skull is distorted “due to excess cerebrospinal fluid, traumatic brain injury, cerebral edema and other conditions in which the pressure within the skull can reach dangerous levels,” the company said.

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