Clearmind Biomedical received FDA 510(k) clearance for its Neuroblade neuroendoscopy system. The novel system enables minimally invasive procedures with integrated features such as visualization, illumination, irrigation, suction, coagulation, and powered debridement. San Jose, California-based Clearmind also announced the first completed U.S. surgery using Neuroblade. Dr. Christopher Kellner performed the procedure at Mt. Sinai Hospital in New York.
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Neuroblade features three components. First, it has a single-use multifunctional endoscope, called the Neuroblade. Next, it features Neuropad, a reusable, medical-grade tablet. Clearpath, the third component, is a disposable, transparent access sheath. Clearmind designed the system to improve the efficiency and outcomes of minimally invasive neurosurgical procedures.
In the initial Neuroblade case, Dr. Kellner used Neuroblade during an urgent procedure to evacuate a hemorrhagic stroke. Clearpath allowed precise access to the target area and Neuroblade provided an all-in-one instrument with real-time visualization and integrated tools.
Kellner called Neuroblade a “valuable new tool” for managing intracerebral hemorrhage. The doctor said its minimally invasive design streamlines the operating room setup and potentially improves outcomes. Kellner believes it could simplify neurosurgical procedures.
“FDA clearance and the first U.S. surgery mark significant milestones for the Neuroblade System, which we believe will revolutionize minimally invasive neurosurgery,” said J. Dustin Duckett, Clearmind Biomedical VP and GM for the Americas. “Developed with input from surgeons, Neuroblade’s integrated features aim to enhance surgical efficiency and patient outcomes. We look forward to further developing evidence, driving adoption, and ultimately getting more patients access to desperately needed care.”
