Tag: fda approval
Mainstay receives expanded MRI labelling from US FDA for ReActiv8 system
Mainstay Medical has announced that the US Food and Drug Administration (FDA) has approved full-body magnetic resonance imaging (MRI) conditional labelling for the ReActiv8...
Perfuze announces US FDA 510(k) clearances for novel aspiration and access...
Perfuze has announced US Food and Drug Administration (FDA) clearances for the Millipede 070 aspiration catheter and the second-generation of its Millipede 088 access...
Nicolab attains US FDA 510(k) clearance for CT perfusion algorithm
Nicolab has announced that its computed tomography (CT) perfusion algorithm, which is integrated into the company’s StrokeViewer platform, has obtained 510(k) clearance from the...
NeuroOne receives US FDA 510(k) clearance to market OneRF ablation system
NeuroOne Medical Technologies Corporation has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance to market its OneRF ablation system for...
EOSolutions receives US FDA clearance for Thinline introducer sheath
EOSolutions Corporation has announced that the US Food and Drug Administration (FDA) has cleared its Thinline introducer sheath—an approval that swiftly follows the successful...
“The tables have turned”—US FDA regulation is becoming the envy of...
Discussions at this year’s European Society of Minimally Invasive Neurological Therapy (ESMINT) congress (4–6 September, Marseille, France) revealed the extent of the disparities between the...
Hyperfine gains US FDA clearance for AI-powered software update of Swoop...
Hyperfine has announced US Food and Drug Administration (FDA) clearance of updated software for its portable magnetic resonance brain imaging technology, the Swoop system....
Nurami receives US FDA 510(k) clearance for resorbable dural repair graft
Nurami Medical, a medical device startup company, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its electrospun nanofibre-based product, ArtiFascia...
US FDA grants de novo marketing request to BlueWind’s Revi system...
BlueWind Medical has announced that the US Food and Drug Administration (FDA) has granted a de novo marketing request for the Revi system—a “transformative”...
Imperative gains US FDA clearance for Zoom 88 support and announces...
Imperative Care has announced US Food and Drug Administration (FDA) 510(k) clearance of its Zoom 88 large distal platform (LDP) support, a portfolio expansion...
Insightec gains US FDA nod for five-year endpoint in MR-guided focused...
Insightec has announced US Food and Drug Administration (FDA) approval of the five-year study endpoint for what it claims is the largest prospective, long-term...
Penumbra expands computer-aided thrombectomy offering with Lightning Bolt 7 launch
Penumbra has announced the US Food and Drug Administration (FDA) clearance and launch of Lightning Bolt 7, which the company claims is the most...
Artiria granted US FDA clearance for real-time, deflectable guidewire
Artiria Medical, a Swiss neurovascular company, has announced that its real-time, deflectable guidewire has been granted 510(k) clearance by the US Food and Drug...
Hubly Surgical gains US FDA clearance for novel burr-hole placement device
Hubly Surgical has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Hubly Drill, which the company describes as an innovative...
Neuromod gains US FDA approval for bimodal neuromodulation tinnitus treatment
Neuromod Devices has announced that the US Food and Drug Administration (FDA) has granted de novo approval to Lenire—the first bimodal neuromodulation device of its kind...
Drug-free migraine treatment gains additional US FDA clearance for preventative use
Theranica has announced that its drug-free Nerivio prescription wearable recently received US Food and Drug Administration (FDA) clearance as a dual-use acute and preventive...
Wallaby/Phenox announces US FDA clearance of Preset thrombectomy device
Phenox, a Wallaby Medical company, has announced the US Food and Drug Administration (FDA) 510(k) clearance of its Preset thrombectomy device for the treatment...
CELLO II balloon guide catheter gains US FDA approval for peripheral...
The CELLO II balloon guide catheter (Fuji Systems Corporation) has received 510(k) premarket approval from the US Food and Drug Administration (FDA), and can...
Imperative Care announces FDA clearance and initial cases with stroke-specific radial...
Imperative Care announced today that the US Food and Drug Administration (FDA) has finalised 510(k) clearance of its Zoom RDL radial access system—the company’s...
Swiss parliament votes to accept US FDA-approved medical devices
The Swiss Federal Assembly has voted in favour of accepting medical devices with US Food and Drug Administration (FDA) marketing authorisation in Switzerland.
A motion...
NeuroOne receives US FDA 510(k) clearance to market Evo sEEG system...
NeuroOne Medical Technologies has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance to market its Evo stereoelectroencephalography (sEEG) electrode technology...
Nevro announces US FDA approval of HFX iQ system to personalise...
Nevro Corporation has announced that it has received approval from the US Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS)...
Phagenesis announces US launch of neurostimulation system for post-stroke swallowing control
Phagenesis today announced that the US Food and Drug Administration (FDA) has granted a de novo request for the Phagenyx neurostimulation system, which uses...
Vesalio announces US FDA approval of NeVa VS to treat cerebral...
Vesalio has announced US Food and Drug Administration (FDA) humanitarian device exemption (HDE) approval for commercialisation of its NeVa VS device, which is indicated...
Abbott gains US FDA approval for Proclaim Plus spinal cord stimulation...
Abbott has announced that the US Food and Drug Administration (FDA) has approved its new Proclaim Plus spinal cord stimulation (SCS) system featuring FlexBurst360...
Rapid Medical gains US FDA clearance for “smallest and only” adjustable...
Rapid Medical announced at the ongoing Society of NeuroInterventional Surgery’s (SNIS) 19th annual meeting (25–29 July, Toronto, Canada) that it has recently received US...
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...
