niamhcurran
Orthofix 3D-printed titanium cervical spacer system receives clearance
Orthofix Medical has announced the US Food and Drug Administration (FDA) has given 510(k) clearance for its 3D-printed Construx mini titanium spacer system. In...
Medtronic receives FDA approval for labelling of Intellis platform when using...
Medtronic has announced that the US Food and Drug Administration (FDA) has approved the revised commercial labelling for the Intellis platform with differential target...
InVictus OCT posterior fixation system for the cervical and thoracic spine...
Alphatec Holdings has announced the launch of the InVictus occipital-cervical-thoracic (OCT) spinal fixation system, which extends the sophistication of the InVictus posterior fixation platform...
4WEB Medical receives FDA clearance for its lumbar plating solution
4WEB Medical, an orthopaedic device company focused on developing innovative implants utilising its proprietary Truss Implant Technology, has announced that the company has received...
Lumbar fusions have better outcomes when evidence-based best practice is followed
A prospective clinical study published in Neurosurgery has found that lumbar fusions were three times more likely to be effective and obtain better patient outcomes...
Trial shows percutaneous PNS could offer “non-destructive, motor-sparing neuromodulation treatment”
Results of a trial published in the journal Pain Medicine reports that percutaneous peripheral nerve stimulation (PNS) show “clinically significant” reductions in pain, disability, and pain...
7D Surgical launches its FLASH navigation system to German and Swiss...
7D Surgical, a Toronto-based medical device company developing optical and machine-vision technologies for surgical navigation, has announced that it has launched its FLASH navigation...
Stronghold 3D titanium interbody device launched
Spine Wave has announced the commercial launch of its Stronghold 3D titanium interbody device featuring TiCell 3D advanced surface technology.
According to a company press...
NuVasive and the International Spine Study Group Foundation announce two new...
NuVasive and the International Spine Study Group Foundation (ISSGF) have announced the continuation of their long-term partnership by launching two new clinical studies focused...
ReVivo Medical changes from an LLC to a corporation
ReVivo Medical has announced that in an effort to attract more investor funding in the future, it has changed its entity classification from a...
First patient enrolled in first real-world outcomes for Medtronic DTM SCS
Celéri Health has announced the first patient has been enrolled in the UPGRADE study which is a large registry of patients using DTM Spinal...
PMA submission process initiated for FDA approval of Limiflex
Empirical Spine, maker of the LimiFlex paraspinous tension band, has announced initiation of the PMA process for the US Food and Drug Administration (FDA)...
Aurora Spine announces launch of its proprietary SiLO posterior SI joint...
Aurora Spine has announced the launch of its proprietary SiLO posterior SI joint fusion system (SiLO), which was designed specifically for posterior sacroiliac joint...
NuVasive acquires Simplify Medical
NuVasive has acquired Simplify Medical, a privately-held company and developer of the Simplify Cervical Artificial Disc (Simplify Disc) for cervical total disc replacement (cTDR).
According...
Fusion Robotics receives FDA clearance for spinal navigation and robotics system
Fusion Robotics has announced receiving 510(k) clearance from the US Food and Drug Administration (FDA) to market their 3D imaging-compatible navigation and robotic targeting...
Study finds deep learning application can identify previous spinal implants
A new study to be published in Spine has found that deep learning applications are able to identify previous spinal implants. In some cases, Hee-Seok Yang...
MiRus announces a lifetime limited warranty on MoRe superalloy rod
MiRus has announced the launch of MoRe Promise, a lifetime limited warranty on its Molybdenum-Rhenium (MoRe) superalloy rod technology. In a company press release,...
First patients implanted with AlloWrap amniotic membrane
AlloSource has announced that the first patients have been enrolled in a randomised controlled study to evaluate the effectiveness of AlloWrap amniotic membrane for...
SeaSpine announces full commercial launch of the Reef TO TLIF oblique interbody system
SeaSpine has announced the full commercial launch of the Reef TO transforaminal lumbar interbody fusion (TLIF) oblique interbody system.
According to a company press release, the Reef TO interbody system is designed for posterior lumbar interbody procedures and...
ReFlow system mini receives FDA breakthrough device designation
Anuncia has announced that it has received US Food and Drug Administration (FDA) breakthrough device designation for its ReFlow system mini, intended for the treatment of cerebral spinal...
ReWalk enter contract with BKK Mobil Oil health insurance fund to...
ReWalk Robotics has announced it has entered into a contract with BKK Mobil Oil Insurance to provide ReWalk personal exoskeleton devices to its eligible...
BrainStorm’s NurOwn does not have enough clinical data according to FDA
BrainStorm Cell Therapeutics announced it recently met with senior leadership from the US Food and Drug Administration (FDA) and received feedback on a high-level data summary...
Medtronic receives FDA approval for expanded MRI labelling of InterStim SureScan...
Medtronic has received approval from the US Food and Drug Administration (FDA) for expanded magnetic resonance imaging (MRI) InterStim II and InterStim Micro sacral...
Brachytherapy cement could be used to treat spinal tumours
Study results presented at the 2021 annual meeting of the Orthopaedic Research Society (12–16 February, virtual) report that a radioactive bone cement could provide...
C2Dx acquires Stryker T/Pump
C2Dx Inc has announced their acquisition of the T/Pump product line from Stryker. According to a company press release, the T/Pump is the second...
Medtronic announces first use in US of Midas Rex drills with...
Medtronic has announced the first use of Midas Rex drills and navigated disc prep and interbodies with the Mazor robotic guidance system for minimally-invasive...
IOF release position paper recommending routine use of VFA-DXA in fracture...
A new position paper published in the journal Osteoporosis International by the International Osteoporosis Foundation (IOF) fracture working group, which urges for the routine...
Philips announces ClarifEye augmented reality surgical navigation for minimally-invasive spine procedures
Royal Philips has introduced ClarifEye augmented reality (AR) surgical navigation, a solution to advance minimally-invasive spine procedures in the hybrid operating room.
Philips claims in...
Zavation Medical Products launches the Labyrinth fully porous PEEK cage
Zavation Medical Products has announced the launch of Labyrinth, a porous PEEK interbody cage. This is the latest addition to Zavation’s portfolio, which the...
NGMedical receives FDA clearance for cervical Bee cage
NGMedical has announced that its titanium cervical Bee cage has received clearance from the US Food and Drug Administration (FDA). According to the company...
TheraCell announces release of TheraFuze DBF Fiber Wrap
TheraCell has announced the first surgical case using its TheraFuze DBF Fiber Wrap. According to TheraCell, this is the third new product in the...
BlackArmour anterior cervical plate launched in the US market
icotec ag has announced the US market release of its BlackArmor carbon/PEEK implants. According to a company press release, it is the world’s first...
Spinal Elements receives FDA clearance for Lucent XP-Curved expandable TLIF device
Spinal Elements has announced that it has received clearance from the US Food and Drug Administration (FDA) for its Lucent XP-Curved expandable interbody device....
Inspired Spine receives FDA clearance for Trident SI Joint Screw System
Inspired Spine has announced that its Trident SI Joint Screw System, for use in the sacroiliac (SI) joint, has received 510(k) clearance from the...
Camber Spine receives US patent for Spira Lateral 3.0
Camber Spine has announced that it has received a notice of allowance from the US Patent and Trademark Office (USPTO) for its Spira Lateral...
SeaSpine announces limited commercial launch of Regatta lateral plate system
SeaSpine has announced the limited commercial launch of its Regatta lateral plate system. This is its first standalone lateral plate.
According to the company, this...
Choosing the ideal surgical approach for improved access to the L5-S1...
Chirag A Berry (Cincinnati, USA) is an assistant professor at the University of Cincinnati College of Medicine. Here he provides a summary of his...
Non-surgical refractory back pain patients have better pain outcomes with 10KhZ...
Findings of a randomised, prospective study suggest that non-surgical refractory back pain (NSRBP) patients have better outcomes with 10KhZ spinal cord stimulation (SCS) and...
Abbott launches NeuroSphere myPath digital health app
Abbott has announced the launch of its NeuroSphere myPath digital health app, designed to track and report patient perceived pain relief and general well-being...
First surgical implant of spinal device coated with N2 Biomedical’s ion-assisted...
N2 Biomedical has announced that the first polyetheretherketone (PEEK) interbody fusion device coated with its titanium coating technology was successfully implanted in a patient....
WaveWriter Alpha SCS systems launches in USA
Boston Scientific has announced that its WaveWriter Alpha spinal cord stimulation (SCS) systems will have a limited market release in the USA. The SCS...
First patient enrolled in Up-LIFT safety and effectiveness trial of ARC...
ONWARD has announced that the first patient has been enrolled in a pivotal trial evaluating its ARC Therapy, according to a company press release....
First surgical use of TheraFuze DBF Fiber Bullets in an interbody...
TheraCell has announced the first surgical use of TheraFuze DBF Fiber Bullets. According to a press release from the company, the DBF Fiber Form...
Study finds single-position spine surgery improves operative efficiency while reducing complications...
NuVasive has announced that a new study published in The Spine Journal could validate single-position spine surgery as having significant advantages over traditional, open...
Stryker launches T7 personal protection system for surgery
Stryker announced the launch of T7, its personal protection system. According to their press release, the T7 and T7plus create a personal protection system...
Endo announces licensing agreement for Paladin Labs to commercialise abaloparatide in...
Endo International announced in a press release that its subsidiary Endo Ventures has entered into definitive agreements with Radius Health to register, commercialise and...
NICE publishes briefing on Saluda’s Evoke closed-loop SCS system
Saluda medical has announced today that the UK’s National Institute for Health and Care Excellence (NICE) issued a Medtech Innovation Briefing (MIB) on Saluda’s...
New findings suggest patients prefer one-stage SCS screening trial
A new study, published in the journal Neuromodulation, has found that patients show a preference for a one-stage spinal cord stimulation (SCS) screening trial,...
Centinel Spine announces first implant of prodisc L Lumbar total disc...
Centinel Spine has announced the first implantation of newly available angled endplates in the USA for the prodisc L Lumbar Total Disc Replacement System....
HSS Bone study finds link between skeletal abnormalities and likelihood of...
A press release by the Hospital for Special Surgery (HSS), claims that the microscopic structure of bone appears to predict which patients will experience...
Medtronic receives FDA device clearance for Mazor platform devices
Medtronic has announced that the US Food and Drug Administration (FDA), has given clearance for the use of its navigated interbody and Midas Rex...
G-21 and icotec ag partner for pedicle screw system
G-21 and icotec ag have announced strategic corporation to use G-21’s bone cement in conjunction with icotec’s VADER pedicle screw system in the USA.
According...
Stryker receives CMS transitional pass-through payment for SpineJack System
The Centers for Medicare and Medicaid Services (CMS) have announced that Stryker’s SpineJack System has qualified for the Transitional pass-through (TPT) payment. The TPT...
Nexxt Spine announces first case with NEXXT MATRIXX SA Cervical Turn-Lock...
Nexxt Spine has announced the first implantation of its NEXXT MATRIXX SA Cervical Turn-Lock system. The system is based around an intentionally engineered 3D...
Motion preservation device market estimated to grow to US$1501.9 million
Transparency Market Research has estimated that the motion preservation devices market is estimated to grow in value to US$1501.9 million by 2027.
The company reports...
Centinel Spine announces 3,500 3D-printed devices successfully implanted
Centinel Spine, a privately-held spine company focused on anterior column reconstruction, has announced its novel FLX technology platform of 3D-printed porous titanium interbody devices.
The...
Studies find FlareHawk expandable cage safe and efficacious
Integrity Implants, has today announced the publication of recent clinical articles in the International Journal of Spine Surgery (IJSS) which highlight the safety and...
Nuvasive announces C360 cervical spine portfolio
NuVasive has announced the launch of its C360 cervical spine portfolio, which includes the commercial launch of its Anterior Cervical Plating (ACP) system. The...
New study first to visually capture biofilm architecture in retrieved implants...
A new study, published in the journal Spine Surgery and Related Research, is the first to visually capture the structure of biofilm on retrieved...
Boston Scientific launches Wavewriter Alpha SCS Systems in Europe
Boston Scientific has launched their Wavewriter Alpha spinal cord stimulator (SMS) systems, to the European market, after receiving their CE mark. This product is...
New study shows re-operation rate for metastases at 8.3%
In a new study published in European Spine Journal, Ahmad M. Tarawneh, Nottingham University Hospital, Nottingham, England, creates a systematic review aimed at analysing...
Implantable brain-computer allows severely paralyses patients to complete daily tasks
The Stentrode brain-computer interface (BCI) has successfully been demonstrated by researchers to help patients with severe paralyses compete tasks such as texting, emailing, shopping...
NuVasive launches Cohere XLIF
NuVasive announced today the launch of their Cohere eXtreme Lateral Interbody Fudion (XLIF), a Porous PEEK interbody for use in XLIF and X360 surgeries.
This...
Astura Medical receives FDA clearance for Dolomite Stand-Alone Anterior System
Astura Medical, Texas, USA, has received 510(K) clearance from the US Food and Drug Administration (FDA) for its Dolomite Stand-Alone Anterior Cervical Stabilization System.
The...
Medtronic finalises acquisition of Medicrea
Medtronic has announced the completion of their acquisition of Medicrea, a platform which uses artificial intelligence (AI) to advance spinal surgeries. Medicrea solution uses...
Canada to be the first commercial market to launch Cerapedics new...
Cerapedics today announced that the Canadian Market would be the first to have the i-FACTOR+ MATRIX surgical implant fully commercially available. The implant will...
Medtronic receive FDA approval for NIM Vital
Medtronic has received their US Food and Drug (FDA) 530(k) clearance of their NIM Vital nerve monitoring system. The NIM system helps physicians identify,...
Nvision Biomedical Technologies receives FDA clearance for first osteotomy wedge system
The US Food and Drug Administration (FDA) has given clearance for the Nvision Trigon Stand-Alone Osteotomy wedge system, made from PEEK-OPTIMA HA Enhanced, a...
Spine patients highly satisfied with telemedicine during COVID-19 according to new...
A study published on the Global Spine Journal on 22 October, reports that 87.7% of spinal patients were satisfied with telemedicine appointments during the pandemic....