Tag: fda approval

scs diabetic neuropathy

High-frequency SCS takes the stage to relieve chronic pain from diabetic...

Following the recent approval of the Senza system (Nevro) by the US Food and Drug Administration (FDA), Erika A Petersen (Little Rock, USA) discusses the...
neuroone evo technology

NeuroOne Medical Technologies gains FDA 510(k) clearance for Evo SEEG electrode

NeuroOne Medical Technologies—a company focused on improving surgical care options and outcomes for patients with neurological disorders—has announced that it has received US Food...
vivistim system

MicroTransponder gains FDA approval for first-of-its-kind VNS system to improve stroke...

MicroTransponder has announced US Food and Drug Administration (FDA) premarket approval of the Vivistim paired vagus nerve stimulation (VNS) system, which—according to a company...
qure.ai

Qure.ai lands second FDA clearance for AI-based brain scan technology

Qure.ai has announced US Food and Drug Administration (FDA) 510(k) clearance for its brain computed tomography (CT) quantification product qER-Quant. Clinicians in the USA...
spintech stage

SpinTech earns FDA clearance for rapid, quantitative brain-imaging technology

The US Food and Drug Administration (FDA) has granted 510(k) approval for STAGE (Strategically acquired gradient echo), the latest magnetic resonance imaging (MRI) technology...
quicktome omniscient neurotechnology

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 senza

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 red 62

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...
pons fda approval

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 vanta

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...