US-based medical equipment company Clearmind Biomedical has received the US Food and Drug Administration (FDA) 510(k) approval for its Neuroblade System for minimally invasive neurosurgery.
The Neuroblade System enables minimally invasive procedures with integrated visualisation, illumination, irrigation, suction, coagulation, and powered debridement features.
The system contains three components – the Neuroblade, the Neuropad, and Clearpath.
Neuroblade is a single-use multifunctional neuroendoscope, Neuropad is a reusable medical-grade tablet, and Clearpath is a disposable transparent access sheath.
The advanced neuroendoscopy system is designed to improve the efficiency and outcomes of minimally invasive neurosurgical procedures, said the medical device company.
Clearmind Americas vice president and general manager Dustin Duckett said: “FDA clearance and the first US surgery mark significant milestones for the Neuroblade System, which we believe will revolutionise minimally invasive neurosurgery.
“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.”
In addition to the FDA approval, Clearmind completed the first US surgery using its Neuroblade System, performed by Dr Christopher Kellner at Mt. Sinai Hospital, New York.
In the initial US case, Dr Kellner used the company’s Neuroblade System during an urgent procedure to evacuate a haemorrhagic stroke.
Clearpath sheath provided precise access to the target area, while Neuroblade offered an all-in-one instrument with visualisation and tools for suction, irrigation, debridement, and coagulation.
Kellner said: “The Neuroblade system offers a valuable new tool for the surgical management of intracerebral haemorrhage.
“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 favourable outcomes.”
