ClearMind Biomedical s Axonpen Neuroendoscope Receives 510K Clearance
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LOS ANGELES, Jan. 11, 2021 /PRNewswire/ ClearMind Biomedical has received FDA clearance for its novel neuroendoscope, the Axonpen System, for illumination and visualization of intracranial tissue and fluids, and the controlled aspiration of tissue and/or fluid during surgery.
First in man clinical trial in operation.
Requiring only a narrow channel of 6.5mm through the skull for insertion into the brain, the steerable Axonpen combines excellent tissue visualization, suction, and irrigation functions. It has a working channel for use with accessory surgical devices. The Axonpen System is the first neuroendoscope to integrate all these capabilities into one, simple to use, minimally invasive operating platform.