ClearMind’s Neuroendoscope Cleared by FDA
The FDA has granted 510(k) clearance for ClearMind Biomedical’s Axonpen neuroendoscope system.
The neuroendoscope has been cleared by the agency for illuminating and visualizing intracranial tissue and fluid and removing the tissue and fluid during surgery.
The minimally invasive device can be inserted through the skull into the brain using a channel of 6.5mm and includes visualization, suction and irrigation capabilities in a single device. The neuroendoscope also features a working channel for use with surgical accessories.