Neurosurgery Device Platform Receives 510(k) Clearance from the FDA

The Food and Drug Administration (FDA) has granted 510(k) clearance to the Neuroblade System (Clearmind Biomedical, San Jose, CA), a neuroendoscopy platform designed for minimally invasive neurosurgical procedures, integrating multiple functions and external devices to provide visualization, illumination, irrigation, suction, coagulation, and powered debridement. Christopher Kellner, MD, a neurosurgeon at Mount Sinai Hospital in New York, NY, performed and successfully completed the first surgery in the United States using the Neuroblade System, according to an announcement from Clearmind Biomedical.

There are 3 components comprising the Neuroblade System:

• The Neuroblade, a disposable multifunctional neuroendoscope
• The Neuropad, a multi-use tablet-based interface
• The Clearpath, a single-use transparent sheath providing access to the device

Following his use of the Neuroblade System to provide urgent treatment to a patient with hemorrhagic stroke, Dr Kellner stated, "The Neuroblade system offers a valuable new tool for the surgical management of intracerebral hemorrhage. Its minimally invasive design streamlines the operating room setup and integrates essential functions into a single handpiece, potentially improving patient outcomes. Neuroblade system represents a new class of technology that should simplify neurosurgical procedures and provide patients a chance at more favorable outcomes."