jamiebell
4WEB Medical receives 510(k) clearance to market new integrated cervical plate
4WEB Medical has announced that it has received 510(k) clearance to market the newest additions to the company's implant portfolio—the Cervical Spine Truss System (CSTS) integrated...
Carlsmed gains US FDA Breakthrough Device designation for Aprevo technology
Carlsmed recently announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation for Aprevo—a technology used in the treatment of...
Saluda receives US FDA approval for MRI labelling of Evoke spinal...
Saluda Medical has announced that the US Food and Drug Administration (FDA) has approved magnetic resonance imaging (MRI) conditional labelling for its Evoke system,...
Onward announces first-in-human implant of ARC-IM stimulator with wireless BCI device
Onward Medical has today announced the successful first-in-human implant of its ARC-IM stimulator intended to restore upper-extremity function after spinal cord injury (SCI). The...
ChoiceSpine announces standalone indication for Blackhawk Ti 3D-printed cervical spacer system
ChoiceSpine recently announced that it has received clearance from the US Food and Drug Administration (FDA) to market the Blackhawk Ti 3D-printed cervical spacer system...
SpineGuard announces presentation of data indicating 100% success rate with DSG...
SpineGuard has announced that a research team presented an article at the 2023 Conference on New Technologies for Computer and Robot Assisted Surgery (CRAS;...
Nevro announces new data demonstrating health economic benefits of 10kHz SCS...
Nevro Corporation has announced the publication of new data validating the health economic benefits of 10kHz therapy, the company’s proprietary, high-frequency spinal cord stimulation...
Boston Scientific to expand neuromodulation portfolio with Relievant Medsystems acquisition
Boston Scientific Corporation has today announced it has entered into a definitive agreement to acquire Relievant Medsystems—a privately held medical technology company that has...
Studies indicate workers’ compensation patients fare worse than counterparts following lumbar...
Two studies recently published in the peer-reviewed Journal of Neurosurgery: Spine have found that workers’ compensation patients undergoing lumbar spine surgery fare worse post-surgery than...
Astura announces initial case and full commercial release for El Capitan...
Astura Medical has announced the full commercial release and first case with its most recent expandable technology, the El Capitan X expandable anterior lumbar...
Informed consent is a critical process for patients and physicians alike...
Even though obtaining informed consent is an important procedure before spinal surgery, almost 40% of the patients in a recent study—published in the European...
Medtronic receives CE-mark approval for Inceptiv closed-loop SCS to treat chronic...
Medtronic has received CE-mark approval for its Inceptiv closed-loop rechargeable spinal cord stimulator in the treatment of chronic pain.
Inceptiv is the first Medtronic spinal...
Wenzel Spine receives US FDA clearance expanding clinical indications for primaLOK...
Wenzel Spine has gained US Food and Drug Administration (FDA) clearance for its primaLOK SP system—marking a "significant advancement in spinal fusion technology", offering...
Viseon announces commercial rollout, initial clinical use of 4K MaxView system
Viseon has announced the US commercial rollout and initial clinical use of a “first-of-its-kind” 4K advanced visualisation system for minimally invasive spine surgery. The...
Health economic data show cost-dominance of Saluda’s EVOKE system over open-loop...
Saluda Medical has announced the publication of new health economic data in the Clinical Journal of Pain that provides “the strongest ever economic case” for the...
‘Intelligent suit’ supported by AI and electrical stimulation could enhance spinal...
Experts in Germany are working on an ‘intelligent suit’ with which they hope to significantly improve rehabilitation after a serious spinal cord injury. This...
Education and collaboration key to continued advancement of painful diabetic neuropathy...
The neuromodulation space has proliferated significantly over the past few years, and one area in which this is most notable is with the expansion...
NeuroSolv seeks to expand development and approval of novel spinal cord...
In partnership with AscellaHealth, NeuroSolv Therapeutics is seeking to expand the clinical trial development programme and accelerate regulatory approval procedures to optimise the prospect...
Stryker announces commercial launch of Q guidance system with cranial guidance...
Stryker has commercially launched its Q guidance system with cranial guidance software to provide surgeons with an image-based planning and intraoperative guidance system that assists...
First SynerFuse procedure performed by solo surgeon in two-level spinal fusion...
SynerFuse has announced that—for the first time in the world, it claims—a solo spine surgeon has performed the SynerFuse procedure in a two-level spinal...
Cochrane Library urged to retract and revise recent SCS review over...
Pain physicians have urged the Cochrane Library to retract and revise a recent review of spinal cord stimulation (SCS) in the treatment of low...
Brain-computer interface plus SCS therapy enables thought-controlled walking after spinal cord...
Onward Medical has announced a recent publication in Nature showing that a wireless brain-computer interface (BCI) can use patients’ thoughts to modulate ARC therapy....
Abbott gains US FDA nod to treat non-surgical back pain with...
Abbott has announced that the US Food and Drug Administration (FDA) has approved its spinal cord stimulation (SCS) devices for the treatment of chronic...
The new standard for SCS therapy—neural activation measurement, targeting and maintenance
Jason Pope (Santa Rosa, USA) discusses closed-loop spinal cord stimulation (SCS) and its potential to provide sustained, holistic outcomes for chronic pain patients. In...
SynerFuse announces presentation of IDE proof-of-concept study data
SynerFuse has announced that Michael Park (University of Minnesota, Minneapolis, USA)—principal investigator for the company’s investigational device exemption (IDE) proof-of-concept study—presented data from the study’s...
Biotronik announces US FDA approval of Prospera spinal cord stimulation system
Biotronik has announced US Food and Drug Administration (FDA) approval for Prospera—a new spinal cord stimulation (SCS) system. The system features RESONANCE, which the...
Review concludes SCS benefits do not outweigh associated risks and costs...
A recently published Cochrane review has concluded that the clinical benefits of spinal cord stimulation (SCS) do not outweigh the risks and costs associated...
NeuroOne completes initial animal implant of thin-film paddle lead for spinal...
NeuroOne Medical Technologies has announced the successful completion of an initial animal implant of its novel, thin-film paddle leads for spinal cord stimulation (SCS)....
UK MHRA awarded £10 million to fast-track patient access to medical...
A total of £10 million has been awarded to the Medicines and Healthcare products Regulatory Agency (MHRA)—an executive agency of the UK Department of...
High-frequency spinal cord stimulation may be associated with “significant decrease” in...
High-frequency spinal cord stimulation (HF-SCS) for treating chronic refractory low back pain (CRLBP) may be associated with a significant decrease in total healthcare costs,...
Nevro announces full US market launch of HFX iQ spinal cord...
Nevro Corporation announced today that it has now initiated the full US market launch of its HFX iQ spinal cord stimulation (SCS) system, following...
Spinal cord stimulation found to “instantly improve” post-stroke arm and hand...
Spinal cord stimulation (SCS) therapy has been shown to trigger instant improvements in arm and hand mobility, enabling people affected by moderate-to-severe stroke to...
SCS therapies can play a role in cancer-related pain treatment despite...
Spinal cord stimulation (SCS) therapies targeting the dorsal column “may be considered” within the multimodal treatment plans typically required by cancer patients, but it...
Boston Scientific announces three-month data from SOLIS trial at NANS
Combination spinal cord stimulation (SCS) therapy with Boston Scientific’s WaveWriter system has demonstrated superior outcomes to conventional medical management (CMM) in chronic pain patients...
Abbott presents new data on streamlining patient-reported measures, BurstDR and more...
Abbott presented new data in more than 30 presentations and posters at the North American Neuromodulation Society (NANS) annual meeting (12–15 January 2023, Las...
Saluda Medical announces presentation of 36-month EVOKE trial data at NANS...
Saluda Medical has announced that late-breaking data from the "landmark" EVOKE clinical trial was presented at the recent North American Neuromodulation Society (NANS) annual...
SynerFuse announces “milestone” solo spine surgeon procedure in DRG stimulation study
Justin Zenanko, the CEO of SynerFuse, has announced that—in what the company says is a world-first—a solo spine surgeon has performed the “groundbreaking” SynerFuse...
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...
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)...
Onward reports positive study results in restoring arm and hand function...
Onward Medical recently announced that the Up-LIFT pivotal study evaluating its non-invasive spinal cord stimulation (SCS) ARC-EX therapy achieved its primary effectiveness endpoint of...
Gimer Medical granted IDE approval for spinal cord stimulation system
Gimer Medical today announced that the company’s spinal cord stimulation (SCS) system was granted conditional investigational device exemption (IDE) approval by US Food and...
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...
Saluda Medical presents data on 24-month holistic response to spinal cord...
Saluda Medical has announced that Steven Falowski (Argires-Marotti Neurosurgical Associates of Lancaster, Lancaster, USA) recently presented late-breaking 24-month data from the company’s EVOKE study at...
High-frequency SCS demonstrates “substantial improvement” in health-related quality of life outcomes
Nevro Corporation has announced that the complete 12-month results from the SENZA-PDN randomised controlled trial (RCT), including health-related quality of life outcomes in patients with...
High responder rates, substantial pain relief and no explants among key...
Nevro Corporation has announced the results from data presentations at the American Diabetes Association (ADA) 82nd Scientific Sessions (3–7 June 2022, New Orleans, USA) supporting the use of...
Medtronic names Laura Mauri as new chief scientific, medical and regulatory...
Medtronic has announced that Laura Mauri has been appointed as the company’s chief scientific, medical and regulatory officer. This appointment adds to Mauri's prior responsibilities...
High-frequency SCS drives impactful outcomes for non-surgical refractory back pain patients
Following the recent introduction of key data supporting the use of high-frequency spinal cord stimulation (SCS) in the treatment of non-surgical refractory back pain...
Multiple-modality spinal cord stimulation demonstrates sustained improvement in chronic pain outcomes
A spinal cord stimulation (SCS) system capable of simultaneously delivering multiple treatment modalities has produced a sustained improvement in outcomes in a randomised controlled...
Nevro announces publication of 12-month data on high-frequency SCS for non-surgical...
Nevro Corporation has announced online publication of 12-month data from the SENZA-NSRBP randomised controlled trial (RCT) in Journal of Neurosurgery: Spine. These data show that...
Updated medical policy expands patient access to Abbott’s DRG stimulation technology
Abbott announced today that UnitedHealthcare (UHC)—the largest private health insurance company in the USA—has updated its ‘Implanted electrical stimulator for spinal cord’ medical policy...
FDA issues two final guidances for including patient perspectives in medical...
The US Food and Drug Administration (FDA) has issued two final guidances providing recommendations for including patient perspectives in medical device clinical studies.
As...
Nevro announces clinical data reinforcing significant and durable benefits of 10kHz...
Nevro Corporation has announced the results from data presentations at the 25th North American Neuromodulation Society (NANS) annual meeting (13–15 January 2022; Orlando, USA) supporting...
Current gaps and barriers in patient access to spinal cord stimulation
Maricela Schnur (St Luke’s Hospital, Duluth, USA) highlights a handful of socioeconomic disparities, racial differences, and psychological and psychiatric factors that currently present difficulties...
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...
Nevro announces FDA approval of high-frequency SCS therapy for painful diabetic...
Nevro has announced receipt of US Food and Drug Administration (FDA) approval for its Senza system to treat chronic pain associated with painful diabetic...
TheraCell announces first surgical uses of TheraFuze DBF Fiber Bag for...
TheraCell has announced the completion of the first two spinal surgeries using its novel TheraFuze DBF Fiber Bag—an allograft alternative to the resorbable polymer...
NuVasive’s Simplify Disc gains FDA approval for use in two-level cTDR
NuVasive has gained FDA approval for its Simplify Cervical Artificial Disc, allowing the device to be used in two-level cervical total disc replacement (cTDR)...