SAN JOSE, Calif. , Aug. 26, 2024 /PRNewswire/ -- Clearmind Biomedical, a leader in medical technology focused on enhancing care for neurosurgery patients, has received FDA 510(k) clearance for its Neuroblade System.
This novel neuroendoscopy system enables minimally invasive procedures with integrated features such as visualization, illumination, irrigation, suction, coagulation, and powered debridement. The company also announced the successful completion of the first U.S.
surgery using the Neuroblade, performed by neurosurgeon Dr. Christopher Kellner at Mt. Sinai Hospital, New York .
The Neuroblade System is composed of three components: the Neuroblade, a single-use multifunctional neuroendoscope; the Neuropad, a reusable medical-grade tablet; and Clearpath, a disposable transparent access sheath. This system is designed to improve the efficiency and outcomes of minimally invasive neurosurgical procedures. J.
Dustin Duckett , Clearmind's Vice President and General Manager for the Americas, stated, "FDA clearance and the first U.S. surgery mark significant milestones for the Neuroblade System, which we believe will revolutionize 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 the initial U.
S. case, Dr. Kellner employed the Neu.