Tag: fda approval
Bendit receives FDA 510(k) clearance for 0.021-inch steerable microcatheter
Bendit Technologies has received US Food and Drug Administration (FDA) 510(k) clearance of its Bendit21 microcatheter for treatment in the neuro, peripheral and coronary...
Aidoc gains FDA 510(k) clearance for AI-supported triage and notification of...
Aidoc has received US Food and Drug Administration (FDA) 510(k) clearance for the triage and notification of brain aneurysm—which affects one in 50 people...
Cerus Endovascular receives FDA clearance for 027 microcatheter products
Cerus Endovascular has received US Food and Drug Administration (FDA) 510(k) clearance for its 027 microcatheters, available in two lengths, expanding on a product...
Insightec announces FDA approval of Exablate Neuro device to treat Parkinson’s...
Insightec has announced that the US Food and Drug Administration (FDA) has approved the Exablate Neuro device for treating advanced Parkinson's disease patients suffering from...
SPR Therapeutics announces expanded FDA clearance for SPRINT peripheral nerve stimulation...
SPR Therapeutics has obtained clearance from the US Food and Drug Administration (FDA) of a broader indication for the usage of its SPRINT peripheral...
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 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...
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 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 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...
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...
