Tag: fda approval
Omniscient Neurotechnology launches Quicktome brain-mapping platform following FDA clearance
Omniscient Neurotechnology has received US Food and Drug Administration (FDA) 510(k) clearance for Quicktome—a digital brain-mapping platform that allows neurosurgeons to visualise and understand...
Nevro announces FDA approval of 10kHz high-frequency SCS therapy for painful...
Nevro has announced receipt of US Food and Drug Administration (FDA) approval for its Senza system for the treatment of chronic pain associated with...
Penumbra receives FDA clearance for RED 62 reperfusion catheter
Penumbra has announced US Food and Drug Administration (FDA) 510(k) clearance and commercial availability of the RED 62 reperfusion catheter—the latest addition to the...
Neuromodulation device for treating MS-related gait deficit receives FDA authorisation
Cambridge Consultants and Helius Medical Technologies have confirmed their “groundbreaking" Portable Neuromodulation Stimulator (PoNS) device—developed for the short-term treatment of gait deficit due to...
Medtronic announces FDA approval of recharge-free Vanta spinal cord stimulation implant
Medtronic has received US Food and Drug Administration (FDA) approval for Vanta—a high-performance, recharge-free implantable neurostimulator (INS) with a device life that can be...
