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    Latest News

    tetrafuse

    RTI Surgical wins 2019 MedTech Breakthrough Award for TETRAfuse 3D technology

    Astura

    Astura Medical announces partnership with Academy Medical

    football

    Low rate of serious upper-spine injuries in NCAA football players

    misonix

    Misonix receives US FDA clearance for integrated ultrasonic surgical platform

    Results of the CSM-Protect RCT indicate a lack of effect on...

    AERIAL

    Globus Medical launches first expandable interspinous fixation

    TLIF IdentiTi posterior curved porous titanium interbody implant system launched

    Microbes on explanted pedicle screws “may be a possible cause of...

    New clinical data demonstrates the versatility of Globus Medical’s ExcelsiusGPS

    image of EOS imaging's platform

    EOS imaging announces 4th system installation at Hospital for Special Surgery

    Best Paper at GSC 2019 addresses burnout among spine surgeons

    New study offers first description of spinal trauma management and its...

    Joimax showcases new electromagnetic navigation system Intracs at GSC and DGNC

    App-based back pain treatment outperforms standard physiotherapy in clinical trial

    Medtronic enters into definitive agreement to acquire Titan Spine

    Boston Scientific announces agreement to acquire Vertiflex

    Study highlights the need for individualised thromboprophylaxis regimens for neurosurgical and...

    radiculopathy

    Cages in ACDF are associated with a higher non-union rate than...

    Relievant announces publication of SMART trial 24-month results

    M6-C

    Orthofix announces first US patient implants of M6-C artificial cervical disc

    Use of artificial intelligence to improve surgical referrals in degenerative lumbar...

    image of EOS imaging's platform

    EOS imaging introduces EOSlink

    Virginie Lafage

    Hospital and patient characteristics can predict extended length of stay in...

    cone of economy

    Advanced method of quantifying the cone of economy may allow practitioners...

    radiculopathy

    Duration of preoperative radiculopathy symptoms associated with worse outcomes

    frailty

    Surgical intervention and sagittal alignment can influence postoperative frailty in cervical...

    Low back pain is significantly improved in the majority of patients...

    New results “strongly support” the safety of the ProDisc-C device

    Spineology mesh interbody fusion technologies yield excellent/good patient satisfaction scores

    M6-C

    Positive two-year data released for the M6-C cervical disc

    Opioid medication use before and during transforaminal lumbar interbody fusion surgery...

    ACDF can be safely performed in outpatient setting in select patients

    Mexico

    EOS imaging intalls the first EOS system in the United Arab...

    tetrafuse

    First patient enrolled in clinical study of Fortilink interbody fusion device

    vertebroplasty

    “No further trials of vertebroplasty should be performed”, report concludes

    New chondrocyte patents for SpinalCyte

    Presurgical CT scan finds significant number of patients had undiagnosed osteoporosis

    RTI Surgical completes acquisition of Paradigm Spine

    Inspired Spine

    Inspired Spine celebrates opening of concierge centre for national and global...

    Scott Gottlieb resigns as head of US FDA

    Si-Bone announces publication of two-year iMIA randomised controlled trial results

    ISASS bone grafting policy statement features i-FACTOR peptide enhanced bone graft

    Vertos Medical granted CE mark for spinal stenosis treatment

    Expanding access to surgery on a global scale

    Single-level anterior cervical discectomy: A “solid alternative” to fusion or arthroplasty

    Atlas Spine launches expandable cervical interbody fusion device

    OrthoPediatrics announces global launch of new BandLoc DUO

    Alphatec announces FDA clearance of automated SafeOp neuromonitoring system

    Outcomes of anterior cervical discectomy and fusion influenced by presurgical depressive...

    Inspired Spine

    Inspired Spine releases study on the clinical and radiological outcomes of...

    Life Spine announces initiation of SIMPACT sacroiliac joint fixation outcomes study

    Ram Haddas

    Cervical decompression surgery found to improve gait and function in adult...

    New computer programme reduces spine surgery errors linked to “wrong level”...

    M6-C

    FDA approval for M6-C artificial cervical disc

    Southern New Hampshire Medical Center installs 7D Surgical platform for spinal...

    Sirakoss granted CE mark for synthetic bone graft substitute

    New implants released for StabiLink Interlaminar System

    Enhanced recovery protocol reduces opioid use in spinal surgery patients

    Editors-in-chief of major cardiovascular journals claim medical misinformation puts “lives at...

    Secure-C cervical artificial disc receives expanded insurance coverage

    Aurora Spine announces new patent for minimally invasive spinal implants

    Mazor X

    Medtronic announces US commercial launch of Mazor X Stealth Edition

    Bioventus launches OSTEOMATRIX biphasic bone graft

    Digital therapeutics company Kaia Health raises US$10m in Series A funding

    shutdown

    US government shutdown disrupting FDA work

    FIREFLY pedicle screw navigation system granted CE mark

    pedicle screw

    Banned in the USA: Petition calls for FDA to prohibit reprocessed...

    Use of opioids before surgery hinders post-surgical improvements

    Stem cells

    SMaRT human neural stem cells found to degrade scar and optimise...

    3D printed implant promotes nerve cell growth to treat spinal cord...

    HoloSurgical announces first surgical procedure utilising ARAI system

    Ulrich medical USA announces entry and first global implantation of expandable...

    Romosozumab receives approval in Japan for treatment of osteoporosis in patients...

    SpineSource acquires French medical device technology

    New international patent for SpinalCyte

    Cell therapy IDCT passes initial safety review of first-in-human clinical trial...

    NuVasive announces new organisational structure and leadership team

    International symposium in Peru: Spineway presents Mont Blanc and Kili product...

    N20: Spine in the spotlight at global meeting

    Digital healthcare partnership aims to reduce low back pain

    Medtronic completes acquisition of Mazor Robotics

    OrthoPediatrics announces full-scale US launch of small stature scoliosis system

    ExcelsiusGPS launched in Europe

    Expanded FDA clearance for NuVasive’s Monolith corpectomy system

    Clinical evaluation of non-surgical degenerative disc disease treatment to begin in...

    Positive payor policy covering coflex for the surgical treatment of lumbar...

    New product innovation award for PEEKplus

    Successful first in human for zLOCK spinal facet joint fixation system

    Joimax introduces Endoscopic Generation 4 Devices and showcases new 3D-printed titanium...

    Spineology announces new board members

    FDA clearance for SAXXONY posterior cervical thoracic spine system

    Mainstay Medical to showcase ReActiv8 and key clinical data at the...

    Minimally invasive placement of pedicle screws may lower incidence of proximal...

    FDA advisory committee to review Evenity (romosozumab) for the treatment of...

    FDA 510(k) clearance for Astura Medical’s spinal fixation system

    University College Hospital advances surgical skills training with adoption of FundamentalVR...

    FDA clears SpinalCyte IND application for universal donor cell therapy to...

    US FDA plan shakeup of its 510(k) clearance programme

    First US clinical use of the Voyant system for minimally invasive...

    Positive payor policy covering coflex by AmeriHealth Caritas for the surgical...

    Zimmer Biomet recalls 1,360 spinal fusion and long bone stimulators

    pulsed radiofrequency

    Pulsed radiofrequency relieves acute back pain and sciatica

    RSNA 2018: Versatile portfolio for most diverse and individual imaging demands

    Eurospine audience sceptical of digital learning’s potential in spinal surgery training

    Statera Spine announces company formation

    NASS Spine Registry

    Surgical intervention found to significantly improve frailty in adult cervical deformity

    Is all ignorance bliss? Expenses for implants in surgery decrease when...

    image of EOS imaging's platform

    EOS imaging announces installations of first EOS systems in Spain and...

    Mazor Robotics shareholders approve US$1.64B Medtronic transaction

    Clinical launch of SurGenTec GraftGun system prefilled with ViBone a resounding...

    Medicrea logo

    Medicrea achieves 3,000 surgery milestone with UNiD ASI and patient-specific implants

    Vertiflex announces 85% reduction in patients using opioids after treatment with...

    Zimmer Biomet Spine announces FDA approval of Mobi-C cervical disc labelling...

    Altus Capital Partners acquires ChoiceSpine

    First ASC in southeast USA purchases Mazor Robotics’ Renaissance system

    RTI Surgical announces HealthPartners’ positive coverage decision for minimally invasive sacroiliac...

    jazz cap

    CE mark clearance for the Jazz Cap System, a screw securing...

    Concorde

    Global orthopaedic devices market worth US$47.7 billion by 2026

    Aurora Spine announces exclusive patent licence agreement for MIS SI joint...

    Biogen scoops sixth Prix Galien award with UK for life-changing rare...

    The world’s first combined endoscopic and robotic-guided spine surgery is performed...

    NuVasive launches Brigade Lateral implant and instrumentation optimised for lateral ALIF...

    K2M

    Stryker closes US$1.4B K2M buy

    Life Spine announces initiation of PROLIFT Expandable Interbody clinical study

    SpinalCyte logo

    SpinalCyte announces sustained 12-month MRI outcomes after CybroCell injection

    Simplify Disc

    Simplify Medical completes enrolment in US IDE pivotal trial of Simplify...

    Children’s Scoliosis Foundation offers members health management app via Backpack Health

    NMPA accepts new drug application for IBI303, a biosimilar candidate to...

    Bio2 Technologies receives FDA IDE approval to begin clinical study of...

    image of EOS imaging's platform

    EOS imaging leadership transition to strengthen US strategy

    robotics

    Costs curbing the rise of robotics in spinal surgery

    RTI Surgical to acquire Paradigm Spine

    Increased radiation but “no benefits” in pedicle screw accuracy with navigation

    NuVasive’s Porous PEEK impant to be used in flagship XLIF procedure

    SpinalCyte logo

    SpinalCyte announces new patents in Hong Kong and Europe

    Spinal Elements announces FDA clearance of Ti-Bond titanium coating as a...

    Southlake Equity leads Series B round of financing to prime Titan...

    Dedicated surgical teams improve quality, safety and value in surgery for...

    Wellness

    International interest in physician wellness escalates

    Virginie Lafage

    Clinical benefits of minimally invasive spinal fusion appear to “diminish” as...

    wearable

    Wearable devices utilising augmented reality will “disrupt the surgical landscape”

    Tetrafuse

    RTI Surgical wins 2018 Orthopedics This Week spine technology award for...

    NuVasive

    NuVasive announces strategic partnership with Biedermann Technologies to access intellectual property

    Cyclists

    Whether commuting or competing, research highlights a worrying trend in the...

    NURTURE

    New data show Spinraza beneficial in the treatment of spinal muscular...

    Medtronic

    Medtronic launches the Infinity OCT spinal system

    market

    Spinal implants market to exceed US$19.5 billion by 2024

    Medtronic Mazor

    Medtronic to acquire Mazor robotics

    Virtual

    ImmersiveTouch launches the first virtual reality integrated suite for surgical planning

    Augmented reality surgical navigation technology enables high accuracy pedicle screw placement

    DePuy Synthes expands spine portfolio with nerve assessment platform designed to...

    CoreLink announces the launch of articulating expandable posterior lumbar system: FLXfit15

    Senza

    Nevro receives TGA approval for Senza II spinal cord stimulation system...

    spinal

    J&J acquires 3D-printed spinal implant maker EIT

    Benvenue Medical

    Benvenue Medical completes divestiture of its vertebral augmentation systems portfolio

    pedicle screw

    Surgeons call for ban on pedicle screw reuse and demand two-step...

    Invuity announces definitive agreement to be acquired by Stryker

    suicide

    Spinal injuries in suicidal jumpers “differ in many aspects” to non-suicidal...

    New positive commercial payor policy covering coflex for the surgical treatment...

    TirboLOX

    Captiva Spine’s TirboLOX-L 3D printed titanium lumbar cages receives FDA clearance

    St. Mary’s Medical Center selected to study use of Tops System

    Mexico

    EOS imaging installs its first site in Mexico

    NURTURE

    NICE draft guidance ‘minded no’ for access to Spinraza for SMA...

    Sphynx

    FDA approval granted for Eden Spine’s Sphynx

    France’s national healthcare system establishes exclusive positive coverage for the triangular...

    NuVasive

    NuVasive unveils spine’s first integrated surgical automation platform

    Quality

    Quality of life after spinal cord injury: Having independent mobility makes...

    New therapy spurs nerve fibres to regrow through scar tissue and...

    NURTURE

    Spinal Muscular Atrophy drug may be effective if started later than...

    K2M

    Stryker announces definitive agreement to acquire K2M

    A novel approach to complex spinal surgeries: The successful use of...

    weight

    Recent findings contradict the common recommendation to rapidly lose weight prior...

    Siemens Healthcare and NuVasive

    NuVasive and Siemens Healthcare to partner on new spine imaging and...

    namilumab

    Phase II proof-of-concept clinical study of Namilumab for ankylosing spondylitis initiated

    second

    Back to back surgeries safe: Second scoliosis surgery of the day...

    Cayman

    K2M receives FDA clearance for Cayman United Plate System

    Simplify Disc

    First patient enrolled in clinical trial evaluating the Simplify artificial cervical...

    Viscogliosi

    Bioventus enters into definitive agreement to divest BMP development programme to...

    IDE

    Cerapedics announces first patients enrolled in IDE clinical trial of P-15L...

    Immune

    The first immune-evasive gene therapy used to treat spinal cord injury...

    concorde

    DePuy Synthes launches Concorde Lift expandable interbody implant for minimally invasive...

    curve

    The amount of curve correction matters for achieving balanced shoulders in...

    reline

    Next generation Reline system launches

    nanotechnology

    FDA clears first nanotechnology PEEK devices for spinal intervertebral fusion

    financing

    Cerapedics announces closing of US$22 million financing

    NuVasive

    Research highlights the importance of spinal alignment in all, not just...

    Mainstay Medical announces the completion of all implants in the ReActiv8-B...

    Online reviews of spine surgeons—staff and office factors may negatively affect...

    Mexico

    20th University Hospital Centre to receive EOS imaging system

    LifeSciences

    FDA clearance granted for Hive-C cervical interbody devices

    Infection

    Scientists are taking inspiration from dragonfly wings to combat orthopaedic surgical...

    Centerline

    First robotically assisted surgeries with Centerline cortical screw and Prolift expandable spacer...

    Research paves way for novel therapy to treat osteoporosis

    financing

    Use of i-FACTOR peptide enhanced bone graft more than doubles fusion...

    Tesera

    Renovis Surgical receives FDA clearance for Tesera Trabecular Technology Hyperlordotic ALIF...

    Taltz Eli Lilly and Company

    Positive top-line results for second phase 3 study of Taltz in...

    Mexico

    First private practice installation of an EOS system in Germany

    Deformity Gupta GSC 2018

    Children with severe spinal deformity at high risk of revision surgery

    FDA A-CIFT SoloFuse HA standalone system

    SpineFrontier receives FDA approval for A-CIFT SoloFuse HA standalone system

    One in five UK doctors say understaffing has affected patient safety

    e-book cover

    Back Pain Centers of America launches free e-book for patients considering...

    NASS Spine Registry

    NASS launches multidisciplinary Spine Registry to “Collect, measure, care”

    First patented single implant sacroiliac joint fusion system receives FDA clearance

    Bone cement solution indicated for treating sacral fractures granted FDA approval

    First porous PEEK spinal implant clinical study validates its use in...

    Opioid dependence in patients with degenerative spondylolisthesis more likely to occur...

    TriStar Centennial Medical Center acquires the first Levó head positioning system

    Mexico

    EOS imaging launches new EOSone private practice programme

    icotec receives FDA clearance to market BlackArmor® Carbon/PEEK interbody cages

    Many surgeons do not use patient-reported outcome measures in spine care

    Novel approach proves mixed reality is a feasible option for future...

    A hydrogel restores breathing after spinal cord injury in animal models

    Fortilink-TS and –L IBF systems with TETRAfuse 3D technology launches commercially

    Factors predicting survival and external validation of 8 prognostic scoring systems...

    Sustained use of opioids before spine surgery increases risk of continued...

    European Commission approves Prolia for patients with glucocorticoid-induced osteoporosis

    CoreLink acquires medical device company Expanding Orthopedics

    Looks do matter—patients claim what doctors wear is important

    Paradigm Spine announces NASS coverage policy recommendation for coflex interlaminar stabilisation

    Spine surgery products market will value $16.7 billion by 2025

    Paradigm Spine receives FDA pre-market approval (PMA) for first of its...

    CIMZIA effective in treating axial spondyloarthritis patients

    Europe braces for harder times in medical device innovation while US...

    Experimental drug restores some bladder function after spinal cord injury

    Rampart One standard ALIF interbody fusion system gains FDA clearance for...

    FDA 510(k) clearance for cervical and lumbar HA PEEK interbody...

    Pivotal clinical trial demonstrates superiority of anular closure compared to standard...

    Camber Spine announces 510(k) approval of ENZA-A titanium ALIF

    Amgen receives positive CHMP opinion to expand use of Prolia (denosumab)...

    Stem cells

    NSI-566 stem cell therapy confers neurological improvement in spinal cord injury...

    Researchers launch study to measure effects of new rheumatologic agent

    More than 15% of osteoporosis patients who take drug holidays suffer...

    Revolutionary robotic treatment for patients with spinal cord injuries now available...

    Surgeons develop a new screening measurement for cervical stenosis in NFL...

    New spinal stimulation technology more effective in reducing pain in patients...

    Spinal anaesthesia safe for high-risk lumbar spinal surgery patients

    Preliminary study suggests drug may help infants with Spinal Muscular Atrophy

    Chronic opioids linked to increased complications after spinal fusion surgery

    Surgeons’ procedural choices have strong influence on risk of distal junctional...

    Low complication rate in percutaneous endoscopic lumbar discectomy via an interlaminar...

    Recovery rates lower and postoperative residual symptoms significantly worsen with age...

    Mexico

    EOS imaging announces new EOS system installations in two US private...

    Bracing superior to exercise for treating spinal curvature in AIS patients,...

    Zimmer Biomet announces 510(k) clearance for Zyston strut open titanium interbody...

    Human vs. robot: Robotic-guided S2AI screw placement “safe, accurate, reliable” in...

    National Scoliosis Center founder Luke Stikeleather named president of Scoliosis Society

    Life Spine announces line extension of PRO-LINK titanium stand-alone cervical spacer...

    Novel endoscopic transforaminal decompression and fusion with VariLift-LX described

    Los Angeles spine surgeon Todd H Lanman earns ‘Leader in Health...

    Reprogrammed stem cell-derived neurons survive long-term in pigs with spinal cord...

    In a break with dogma, myelin boosts neuron growth in spinal...

    Expanded commercial release of Clutch interspinous process device

    VERTOS IV raises doubts about vertebroplasty

    A neurosurgeon’s perspective on Michael Jackson’s gravity-defying Smooth Criminal tilt

    Immediate restoration of voluntary movement with epidural spinal cord stimulation in...

    Change in policy allowing overlapping surgery decreases length of stay in...

    Scientists map key brain-to-spinal cord nerve connections for voluntary movement

    Few patients maximise opioid-sparing medications after orthopaedic surgery

    First patient treated in US clinical trial of IDCT for degenerative...

    FDA approval for Infuse Bone Graft in expanded spinal surgery indications

    Auto-registration more clinically accurate than point-to-point registration in navigation assisted spinal...

    NURTURE

    Scotland leads the way in approval of first licensed treatment for...

    Mexico

    EOS imaging announces 15th installation in Australia

    Endangered salamander offers clues on healing spinal cord injury

    For heavy lifting, use exoskeletons with caution

    First dynamic spine brace—the robotic spine exoskeleton—characterises spinal deformities

    Neurokinex Kids paediatric rehabilitation facility opens in Crawley, UK

    Belgian surgeon Marek Szpalski named ISASS president 2018—2019

    Preclinical studies of a non-invasive cell therapy for DDD highlight its...

    Disability scores improve for all patients undergoing surgery with a Luna...

    Stryker spine division’s Tritanium C anterior cervical cage gains momentum with...

    Gauthier Biomedical announces 510(k) FDA approval to market Intellitorq

    Therapeutic Goods Administration requests additional clinical data on Mainstay Medical’s ReActiv8

    First clinical use of SENTRY 2 lateral plating system announced by...

    RTI Surgical reaches global milestone of providing 8 million biologic implants...

    CTL Medical gains FDA clearance for Seurat Universal pedicle screw

    SpinalCyte announces MRI evidence of disc regeneration following phase 1/phase 2...

    CTL Medical secures FDA approval for its MATISSE Titanium-PEEK ACIF cage...

    Research shows NuVasive porous PEEK structure maintains high porosity after impaction

    Scoliosis Research Society collaborates with corporate partners and International Spine Study...

    Study validates software tool to assess mortality risk in older patients...

    Intervertebral disc narrowing greater in women than men in an elderly...

    Cerapedics receives FDA approval to initiate IDE study of P-15L bone...

    Helmet use is associated with a reduced risk of cervical spine...

    Brain capillaries trigger spinal motor neurons to develop

    Camber Spine Technologies announces first 100 implantations of SPIRA-C Open Matrix...

    Spineology completes enrollment in IDE trial for mesh fusion implant

    Could an injection replace surgery for osteoarthritis patients?

    Experimental therapy restores nerve insulation damaged by autoimmune disease

    SPINRAZA responsible for improved motor function in later-onset SMA sufferers

    New algorithm decodes spine oncology treatment

    Taltz Eli Lilly and Company

    Lilly announces positive top-line Phase 3 results for Taltz in Ankylosing...

    Durability and sustainability of decompression procedures extended with coflex

    image of EOS imaging's platform

    EOS imaging announces new installation in a top-ranking speciality orthopaedic hospital in...

    Simplify Medical closes additional US$23.25 million in second tranche of series...

    Bioventus to co-develop next generation bone allograft with LifeLink

    Biogen optimistic that the first treatment for spinal muscular atrophy is...

    Astura Medical announces initial cases and full commercial release for Bridalveil...

    FDA releases final rule on acceptance of data from clinical investigations...

    Nerve networks for walking originated in ancient fish

    Orthofix announces 510(k) clearance and US limited market launch of FORZA...

    Back pain

    Mount Sinai Researchers Discover Possible Link between Diet and Back Injuries

    Stem cells

    New study offers hope for recovered motor function in patients with...

    First cases using the Triojection System to treat disc herniation completed...

    State-of-the-art orthopaedic technique may help to identify which cervical radiculopathy patients...

    Johnson & Johnson merges global healthcare education programmes

    Kleiner Device Labs announces full commercial availability of a new spinal...

    Life Spine announces sales growth of ProLift Expandable Spacer System for...

    Spineology completes first lateral post-market study cases using novel implant design

    Precipitating events associated with successful radiofrequency ablation of lumbar facet joint...

    RTI Surgical announces acquisition of Zyga Technology

    Vertera Spine Cohere

    NuVasive extends porous PEEK interbody to TLIF and PLIF procedures

    Anne Mannion presents at Eurospine 2017

    Abstract submissions now open for EUROSPINE 2018

    Gabriel Tender

    Minimally invasive TLIF procedure results in shorter hospital stay and “good...

    image of EOS imaging's platform

    EOS imaging awarded scientific innovation prize

    Camber Spine Spira-C

    Spira-C cervical interbody cleared by US FDA

    The Concorde Clear minimally invasive discectomy device

    DePuy Synthes’ Concorde Clear minimally invasive discectomy device launched in Europe,...

    Omnia Medical VBR

    Omnia Medical gains FDA clearance for vertebral body replacement system

    Spinal fusion device market expected to grow to US$11 billion by 2025

    Spinal fusion device industry to be worth US$11 billion by 2025

    CG Bio’s Novosis bone graft is the first developed in South Korea that contains rhBMP-2

    South Korea’s first rhBMP-2 bone graft receives government recognition

    Image-guided pulsed radiofrequency provides relief from low back pain

    I-factor peptide-enhanced bone graft

    Peptide-enhanced bone graft outperforms autograft at two years

    Selam, Ethiopia, intact skull feature image

    Modern spinal structure established millions of years earlier than previously thought

    Tiger Woods to return to competitive golf after lumbar spine fusion surgery

    Tiger Woods will return to competitive golf seven months after fourth...

    Park Ridge Health awarded Spine Center of Excellence by Joint Commission

    US health centre awarded Spine Center of Excellence certification

    Medicrea IB3D TB cage

    IB3D 3D-printed interbody devices cleared by US FDA

    Can the C7 slope substitute the T1 slope?

    Can the C7 slope substitute the T1 slope?

    Solomon Wilcots interviews Vikas Kapoor at NASS 2017

    NFL broadcaster Solomon Wilcots interviews doctors at EUROSPINE and NASS

    Blood pressure is one of the components in calculating a patient's Rothman Index

    Rothman Index is a useful predictive tool for identifying patients likely...

    An astronaut outside the International Space Station

    Study of astronauts reveals new clues for low back pain mechanisms

    Scoliosis in a 15-year-old

    Researchers narrow in on genetic causes of scoliosis

    Titan Spine Endoskeleton range

    Australian surgeries mark first use of Titan Spine’s Endoskeleton interbody

    medtronic prestige LP for artificial disc replacement

    Two-level artificial disc replacement “an effective alternative” to fusion at 84...

    IFuse 3D plus autograft bone growth

    “Significantly more bone infiltration” with 3D-printed triangular sacroiliac joint fusion implants

    Metronic Intellis

    Non-opioid alternative for chronic pain approved in Europe

    Paralysed Veterans of America

    Grant applications for spinal cord injury or disease now open from...

    Steve Couldwell named CEO of Tissue Regenix

    Steve Couldwell appointed CEO of Tissue Regenix Group

    Stim onTrack wins Spine Technology Award 2017

    Stim onTrack mobile app wins 2017 Spine Technology Award

    Driving your patient engine can help grow your practice

    What are “patient engines” and why should you care?

    Levo head positioning system

    Levó head positioning system for spine surgery by Mizuho OSI introduced...

    Trump declares opioid crisis

    Trump declares opioid crisis a public health emergency

    Viper Prime, simplifying minimally invasive surgery

    Simplifying minimally invasive surgery: DePuy Synthes launch new systems at NASS...

    Robotic-guided spine surgery results in five-fold decrease in surgical complications

    Nuvasive have announced the released of the porous titanium Modulus XLIF

    Nuvasive launches 3D-printed porous titanium implant Modulus XLIF

    MRI of the lumbar spine of two subjects

    New biomarker offers improved method to image degeneration

    The 3D-printed sternum waiting to be implanted

    Success for first personalised, 3D-printed sternum implant procedure in USA

    Life Spine announces alpha release of the Sentry ALIF plating system

    Rigid, low-profile design ALIF system receives alpha release

    Camber Spine presenters will speak at NASS 2017

    Camber Spine announce presenters for NASS 2017

    US doctors urged to take action on gun violence

    minimally invasive surgery

    Minimally invasive decompression linked to lower reoperation, less slip progression and...

    K2M logo

    Eric Major elected chairman of K2M Board

    hd lifesciences nanohive alif device spinal news

    NanoHive lumbar interbodies receive FDA clearance

    Spineology Elite

    Spineology initiates full market release of Elite expandable interbody fusion system

    Nexxt Spine Nexxt Matrix

    US FDA clears Nexxt Spine’s Nexxt Matrixx system

    Zimmer Biomet

    Zimmer Biomet launches Avenue T TLIF cage

    DiscGenics logo

    DiscGenics’ IDCT Investigational New Drug application accepted by US FDA

    Paradigm Spine logo

    Paradigm Spine receives first US private payer coverage for Coflex

    Medicrea UNID lab

    Fracture rates plummet with personalised rods

    Expanding Orthopedics FLXfit

    US FDA clears EOI’s FLXfit15 expandable cage

    Vertebral segmentation

    Researchers pause vertebral segmentation clock

    Network

    Artificial intelligence predicts complications better than logistic regression

    Providence DTRAX

    US FDA clears Providence’s Ally posterior cervical fixation system

    Medicrea UNID lab

    World-first 360-degree personalised spine surgery takes place in UK

    Implanet Jazz platform

    Two new US patents for Implanet’s Jazz platform

    Stryker reaches 100 surgeon milestone for “game-changing” Serrato screws

    One-year data reveal superior pain improvements for SI-Bone Ifuse

    SpineGuard Pediguard

    SpineGuard promotes three key staff members

    Highmark to cover non-Ifuse sacroiliac joint fusion systems

    Mouse

    Non-antibiotic strategy might prevent infections in patients with spinal cord injuries

    Band-Lok

    Band-Lok receives two new US patents

    Brainlab Elements Spine

    US FDA clears Brainlab’s Elements Spine indication-specific radiosurgery software

    Jonathon Singer named chief financial officer of RTI Surgical

    Nuvasive logo

    US FDA clears Nuvasive’s redesigned Magec system

    Implanet Jazz Passer

    Implanet granted US FDA clearance for Jazz Passer

    Mazor X

    CE mark for Mazor X Surgical Assurance platform

    SpinalCyte logo

    SpinalCyte granted new Australian patent

    Titan Spine Endoskeleton

    Chad Kolean appointed chief financial officer of Titan Spine

    Stryker Tritanium C

    US FDA clears Stryker’s Tritanium C anterior cervical cage

    Flexible battery could revolutionise implanted devices

    Metronic Intellis

    US FDA approves Medtronic’s Intellis spinal cord stimulation device

    Carevature logo

    Carevature’s Dreal lumbar decompression system shows enhanced foraminotomy efficiency

    K2M logo

    K2M launches Everest minimally invasive XTower instrumentation

    US FDA clears Spinal Resources’s Swedge pedicle screw system

    Jason Hannon

    Jason Hannon to replace Peter Crosby as Mainstay chief executive officer

    NuVasive announces market launch of LessRay

    Two-year results show statistical superiority of Cerapedics’ I-Factor to autograft in...

    Nuvasive acquires Vertera Spine

    NuVasive acquires Vertera Spine

    First patient enrolled in long-term Infuse posterolateral fusion study

    NuVasive headquarter expansion plans innovation center

    NuVasive to open innovation centre in San Diego, USA

    Joimax opens first Training and Education Center

    First cases using multiple in-situ expansion methods performed with Life Spine’s...

    InVivo halts enrolment in cervical study of neuro-spinal scaffold, lays off...

    Highmark to cover SI-Bone Ifuse system

    US FDA clears Xtant Medical’s new Calix-C cervical interbody footprints

    Spine Wave to launch Proficient posterior cervical spine system

    US FDA clears Globus Medical’s Excelsius GPS robotic system

    Expanding Orthopedics Inc receives two more US patents

    Minimus Spine Triojection abstract chosen as “Featured Paper” at CIRSE 2017

    US FDA grants clearance to Renovis for Tesera 3D-printed interbody fusion...

    New MRI tool offers improved method of imaging degeneration

    Stark increase in opioid-related admissions, deaths in US ICUs

    Capture the Asian market with NASS’s expert-led workshops

    NASS Annual Meeting Exhibition

    Counting down to the largest event in spine

    US FDA clears Stryker’s Serrato pedicle screw

    Nuvasive logo

    Rajesh J Asarpota appointed as Nuvasive’s chief financial officer

    Camber Spine launches Spira open matrix ALIF device

    US FDA clears Stimwave’s full-body MRI-ready wireless peripheral nerve stimulator

    Bioventus announces new executive appointments

    Providence DTRAX

    Australian regulatory body approves Providence’s DTRAX line

    K2M logo

    K2M acquires exclusive license to expandable spinal implant patents

    Intralink-Spine’s Réjuve system effective at 12 months

    Two new patients convert in Invivo Therapeutics’ INSPIRE trial

    ApiFix spinal implant receives Australian Therapeutic Goods Administration certification

    Camber Spine exceeds 150th Enza ALIF implantation

    AlloSource releases AlloFuse line extension

    Globus Medical acquires robotics developer KB Medical

    First clinical use of Life Spine’s TiBow expandable spacer system

    Medicrea UNiD rods

    World-first minimally-invasive spine surgery performed using Medicrea’s patient-specific implants

    First US surgeries performed using 4WEB Medical’s Lateral Spine Truss system

    Mainstay Medical’s ReActiv8 clinical trial passes enrolment mid-point

    Mouse

    New surgical strategy offers hope for repairing spinal injuries

    SurGenTec’s Graftgun receives core patent for post filling cages using graft...

    US FDA clears Vertera Spine’s porous PEEK Coalesce LIF device

    US Food and Drug Administration clears CTL Medical’s Matisse ACIF cage

    French doctors outline response to attacks in Paris and Nice

    Richard Grant to advise Spinal Simplicity

    ReNetX Bio launched to investigate neuro-regenerative technology

    SpinalCyte granted new Japanese patent

    Premia Spine begins Tops system US FDA IDE study

    EIT receives US FDA 510(k) approval for entire 3D-printed cage portfolio

    ApiFix closes Spanish distribution deal

    Simplify Medical closes US$21 million for two ongoing pivotal trials

    Positive pain relief and function results for Amniox Clarix 100 in...

    image of EOS imaging's platform

    EOS Imaging appoints Pierre Schwich as chief financial officer

    Zimmer Biomet

    David Dvorak resigns as Zimmer Biomet president and chief executive officer

    US FDA clears Prosidyan Fibergraft bone graft putty for posterolateral spinal...

    K2M logo

    K2M and Medicalnext sign exclusive distribution agreement for Japan

    Mouse

    Positive pre-clinical results for Scholar Rock’s SRK-015 therapy in spinal cord...

    SeaSpine releases Skipjack expandable interbody system

    Michael Enxing appointed Vertiflex vice president, chief commercial officer

    Jason Blain promoted to president and chief operating officer of Spinal...

    Xenco Medical launches disposable ASC Cervikit across the USA

    SeaSpine launches Mariner posterior fixation system

    US FDA clears Stryker’s Multigen 2 radiofrequency generator

    World-first Microsoft HoloLens augmented-reality discectomy takes place in USA

    Expanding Orthopaedics receives CE mark for expandable FLXfit 15 cage with...

    First UK centre joins Invivo Therapeutics’ INSPIRE study

    CTL Medical to partner with G-21 biomaterials company

    Researchers trace the history behind JFK’s four spine surgeries

    Stéphane Bette to take over from Pierre Jerome as SpineGuard chief...

    Medacta introduces MectaLIF Anterior Hybrid configuration

    Study details key concerns for looking after the spines of elite...

    K2M receives USA FDA clearance and CE mark for Nile Proximal...

    European consortium to develop innovative implants by electrospinning

    Life Spine’s Prolift and Tibow spacers receive Osseo-Loc titanium surface treatment

    Back pain

    Radiofrequency denervation fails to provide clinically important chronic low back pain...

    SpineGuard to expand DSG applications with dental implantology licensing deal

    UK hospital failed to act lawfully when sharing patient data with...

    ChoiceSpine launches biologics portfolio

    EUROSPINE forgoes delegate bags and paper programmes to improve green credentials

    DePuy Synthes launches Viper and Expedium fenestrated screw systems in the...

    K2M logo

    K2M releases Capri Small 3D Static corpectomy cage system

    US FDA clears Meditech’s Cure lumbar plating system

    UCHealth Memorial Hospital new site for InVivo Therapeutics’ INSPIRE study

    DePuy Synthes acquires nerve localisation company Sentio

    US FDA clears Spineology’s Rampart One anterior lumbar interbody fusion system

    Two InVivo Therapeutics INSPIRE patients convert AIS grade

    New patient enrolled in InVivo Therapeutics’ INSPIRE study

    Autologous stem cell injections for degenerated discs well-tolerated in dogs

    Back pain

    Patents filed for use of immune cell-stimulated angiogenesis as low back...

    Sugar nanostructures reduce required BMP-2 by a hundredfold

    One hundred times less BMP-2 required for fusion using glycopeptide nanostructures

    Zyga receives new US patent for SImmetry sacroiliac joint fusion system

    K2M releases Mojave PL 3D first-to-market expandable interbody system

    “Alarmingly high” number of interpretive errors and inconsistencies in MRI examinations

    Implanet announces the commercial launch of the new Jazz Braid in...

    SpineGuard signs exclusive Chinese distribution agreement for PediGuard

    Yoga as effective as physical therapy for chronic low back pain

    New patient enrolled in InVivo Therapeutics INSPIRE study

    US FDA clears Medicrea’s UNID Hub Adaptive Spine Intelligence digital portal

    UK public health groups launch “Everyday Interactions” toolkit to measure professionals’...

    K2M introduces Sahara AL expandable stabilisation system

    Informative biomarkers for tracking SMN-modulating spinal muscular atrophy therapies remain elusive

    Meditech Spine lumbar fusion devices receive US FDA clearance

    Neurostimulation protocol reduces spasticity in spinal cord injury

    Vertera Spine Cohere

    US CMS issues new code to track use of radiolucent porous...

    SI-Bone launches new 3D-printed porous Ifuse-3D sacroiliac joint fusion device

    Medovex receives CE mark approval for Denervex

    3D stem cell-generated skin treats congenital spinal defect in rodents

    Fukushima researchers find significant association between disaster-related stress and low back...

    Ultra-low radiation imaging with image-enhancement software “substantially decreases” radiation dosage

    Premier US healthcare improvement company to offer Bioventus’ full surgical portfolio

    CE mark for EOI’s FLXfit cage with 15 degrees of lordosis...

    Three podium presentations demonstrate positive results for Zimmer Biomet’s Mobi-C

    ANVISA approves Vexim’s SpineJack implants in Brazil

    NuVasive appoints Skip Kiil executive vice president, International

    Aurora Spine to offer Polyaxial Zip ISP technology for out-licensing

    InVivo to include international registry data in sister study to INSPIRE

    EFORT Congress calls for better medical training for treatment after terror...

    Zimmer Biomet

    Zimmer Biomet recalls implantable spinal fusion stimulators

    CE mark approval for Stimwave’s world-first fully percutaneous spinal cord stimulator...

    SurGenTec receives US patent for Graftgun bone graft delivery system

    K2M launches Mesa 2 Cricket extension for complex deformity correction

    Zimmer Biomet mandates corrective action for certain Rosa Spine models

    SMART trial shows nerve ablation “well-tolerated and effective”

    Modern spinal structure established millions of years earlier than previously thought

    Xtant Medical enters into licensing agreement for Site Medical’s OsteoSync Ti...

    Institutional review board approves Life Spine’s electrodiagnostic functional assessment study

    New data released for Intralink-Spine’s Réjuve treatment for low back pain

    Life Spine launches Prolift lordotic expandable interbody solution

    Exhibit your technology at “one of the most anticipated meetings” in...

    SOAP clinical research presentations demonstrate benefits of Rivanna Medical spinal navigation...

    image of EOS imaging's platform

    New York University Langone installs third EOS system

    SI-Bone Ifuse

    US military’s Tricare health care programme offers minimally invasive sacroiliac joint...

    OLLIF procedure cuts procedure time in half, Inspired Spine reports

    Get online with #NASS

    KnowYourBack offers invaluable resource for spine patients

    SpineConnect reaches 3,000 post milestone

    IZI Medical Products acquires Cook Medical’s vertebroplasty line

    Gain insight into biologics and spine innovations at this years’ Summer...

    US FDA clears Life Spine’s Cranial Fusion system

    US FDA approves IDE study for Premia Spine’s Tops system

    Tiger Woods undergoes MIS ALIF for severe back and leg pain

    Titan Spine Endoskeleton

    Titan Spine appoints Ed Graubart as vice president of Professional Development

    VTI partners with Turkish distribution company Medikon

    New patient enrolled in InVivo INSPIRE study

    First commercial implantation of ReActiv8 in Ireland takes place

    Medtronic revises indications for use of Navlock trackers following patient deaths

    Back pain

    Study maps molecular pathways of disc degeneration

    WWII chemical-weapon antidote shows promise as treatment for spinal cord injury

    EOF to become largest Eurasian interdisciplinary event in traumatology and orthopaedics

    CE mark for Implanet’s standalone Jazz implant

    Fiftieth EOS system installed in France

    Amedica receives Australian clearance to commercialise Valeo silicon nitride spinal implants

    SI-Bone Ifuse

    Si-Bone Ifuse sacroiliac joint fusion procedure reaches 25,000 milestone

    Innovasis recieves FDA 510(k) clearance for PEEK standalone Ax ALIF System

    Full market release announced for Nexxt Spine’s Inertia Corti-fixx pedicle screw...

    Methadone may reduce need for opioids after fusion surgery

    Jeffrey Goldstein named president of the International Society for the Advancement...

    Mouse

    Discovery offers new hope to repair spinal cord injuries

    Z-Medical appoints chief commercial officer and US vice president of sales

    Assessment of sagittal balance following TLIF: Are we kyphosing the lumbar...

    Medtronic launches most advanced StealthStation for neurosurgery

    Titan Spine reaches one thousand Nanolock implantations milestone

    image of EOS imaging's platform

    First two EOS Imaging systems to open in China

    7D Surgical enters into US distribution agreements for image guidance system

    Vexim launches Masterflow Plus low-energy osteoporotic fracture treatment in Germany

    NuVasive launches Reline Trauma portfolio

    Porous PEEK demonstrates greater osseintegration than micro-textured titanium

    Running significantly benefits human intervertebral discs

    DePuy Synthes spine logo

    DePuy Synthes acquires bone defect-treating 3D printing technology

    NASS’ allograft and spinal cord stimulation coverage recommendations open for public...

    US FDA clears Life Spine’s Plateau-C Ti cervical spacer system

    Hundredth patient enrolled in clinical study of Zyga’s SImmetry sacroiliac joint...

    Medovex partners with Technology Consult Berlin for distribution in Germany

    Five hundred Inspired Spine minimally invasive OLLIF procedures completed

    Bridging bone found in 94% of Zyga SImmetry patients at 24...

    Amendia aquires Spinal Elements

    First patient treated with Simplify disc in US pivotal trial

    Safe Orthopaedics products listed by AP-HP Paris Hospitals

    Mazor X

    US FDA clears Mazor Robotics’ Mazor X Align deformity correction software

    USTPO grants patent to Aurora Spine for polyaxial Zip interspinous device

    Brian May joins Spine Wave as executive vice president, research and...

    Alphatec Spine launches Battalion lateral system with Squadron retractor

    Aesculap launches spine device warranty for PlasmaporeXP-coated interbodies

    UK NICE recommends sacroiliac joint fusion for chronic sacroiliac pain

    First-in-human stem cell clinical trial for spinal injury expands

    Man moves paralysed legs using spinal cord stimulation

    SpinalCyte receives new European patent

    image of EOS imaging's platform

    EOS imaging announces first sale of EOS system in Israel

    ReActiv8’s clinically important disability, pain and quality-of-life improvements sustained at one-year

    Most “Big Data” research has “very low” academic impact

    Surgery for degenerative cervical myelopathy is “cost-effective” and “should be supported”

    Providence receives FDA clearance for Cavux cervical cage and Ally facet...

    Organogenesis acquires NuTech Medical biologics division

    First surgery using Z-Medical’s MIS Z-Pedicle system performed in USA

    Music therapy reduces postoperative pain in spinal surgery patients

    InVivo Therapeutics announces first Canadian site for cervical spinal cord injury...

    First-time US FDA clearance for Nuvasive’s greater than two-level cervical interbody...

    Seventh InVivo Therapeutics INSPIRE patient converts AIS grade

    Burst Biologics initiates prospective multicentre clinical study in spinal fusion

    InVivo Therapeutics announces new cervical spinal cord injury study

    First US implantation of Spineway’s Mont-Blanc minimally invasive implant takes place

    Safe Orthopaedics to expand into Germany

    Gary Henley to serve as advisor to Spinal Simplicity

    Bioventus to invest in new clinical research for Exogen

    Loss of partner to suicide linked to increased risk of disc...

    Surgeons successfully remove parasitic rachipagus twin

    One step closer to halting the “relentless cascade” of disc degeneration

    Study cautions against use of bone morphogenetic proteins in children’s spine...

    Medtronic logo

    Medtronic announces new US bone cement indication for treating sacral fractures

    Spineology Elite

    US FDA clears Spineology Elite for narrower size and expanded indication

    First implantation of Spine Innovation’s expandable interbody fusion cage takes place

    InVivo Therapeutics enrols Keck Hospital patient into INSPIRE study

    Degree of spinal deformity affects hip replacement surgery success

    UK’s NICE issues updated guidance on lateral interbody fusion procedures

    SpineGuard and Zavation announce first 20 successful cases performed in USA

    Stryker to introduce new Tritanium PL cage sizes at AAOS 2017

    K2M logo

    K2M to debut Balance ACS at AAOS 2017

    image of EOS imaging's platform

    EOS imaging announces third sale to Nemours Children’s Health System

    Simplify disc “may minimise the need for post-surgical CT scans”

    World-first implantation of 3D-printed vertebrae takes place in Australia

    LinkSpine appoints Tom McLeer vice president of Sales and Marketing

    US FDA clears Stryker’s AVAflex balloon system

    Muslim prayer habits can reduce lower back pain

    Safe Orthopaedics expands into Germany

    Alphatec’s Arsenal deformity AIS system launched in limited US markets

    US FDA clears Amend Surgical NanoFuse BA

    Multidisciplinary team approach can reduce spinal fusion overutilisation

    Back pain

    Back pain associated with increase in all-cause mortality

    Implanet granted French patent for Jazz Lock

    GS Medical USA announces new product portfolio

    Joimax obtains full product registration in Thailand

    Wenzel Spine completes acquisition of OsteoMed interspinous and facet fixation platforms

    First clinical cases performed using Philips’ augmented-reality surgical navigation system

    Pelvic incidence shown to be variable in over 80% of healthy...

    First clinical use of Philips’ augmented-reality surgical navigation system takes place

    TranS1 launches Capital bone graft harvester

    Jeffrey R Binder joins Minimus Spine Board of Directors

    Report details plethora of serious health problems faced by spinal cord...

    Placebo and diazepam equally effective for acute low back pain in...

    Safe Orthopaedics launches new products to treat traumatic injuries associated with...

    Nanovis announces the 2,000th FortiCore interbody implantation

    K2M launches Balance ACS 3D platform

    American College of Physicians recommends complementary medicine over drug therapy for...

    Alphatec Spine appoints David H Mowry to its Board of Directors

    RTI Surgical names Camille Farhat chief executive officer

    US FDA clears Spinal Simplicity’s Minuteman G3-R removable end fusion implant

    Vertebral Technologies announces group purchasing organisation contract with ROi

    Two-year USA IDE clinical study follow-up completed for AxioMed Viscoelastic lumbar...

    DePuy Synthes launches ViviGen Formable cellular bone matrix

    Minimally invasive surgery “safe and effective” treatment for adolescent idiopathic scoliosis

    Expert faculty debate contemporary spinal surgery across the globe

    Innovation in precision medicine and intelligent orthopaedics at WOISE2017

    Applying minimally invasive surgery to complex spine in Indonesia

    Get hands-on with the latest innovations in lumbar procedures in Guangzhou,...

    Back pain

    JAAOS article outlines guidance for hip-spine syndrome diagnosis

    SpineGuard Pediguard

    USPTO grants SpineGuard patent for use of DSG as a bone-quality...

    ChoiceSpine releases Harrier ALIF system

    Vexim receives Chinese and Japanese patents for SpineJack

    SeaSpine launches Vu a.Pod prime nanometalene ALIF system

    SpineSource to distribute Kisco’s L-Varlock expandable lumbar cage in the USA

    Decortication and bone-grafting may “contribute to earlier fusion” following sacroiliac joint...

    EUROSPINE offers advice on preventing “text neck”

    First commercial implantation of Mainstay Medical’s ReActiv8 performed in Germany

    Safety study of Intralink-Spine’s Réjuve nears completion as multicentre pivotal study...

    ChoiceSpine acquires Exactech’s spine assets, launches Harrier ALIF system

    US FDA and Health Canada clear 7D Surgical’s image-guided system for...

    DePuy Synthes spine logo

    DePuy Synthes to co-promote Pacira’s Exparel non-opioid analgesic

    USPTO grants VTI patent for InterCushion modular motion preservation implant

    DePuy Synthes receives US FDA clearance for cement-augmented pedicle screw systems

    US FDA clears Camber Spine’s Siconus sacroiliac joint fixation system

    Securities and Exchange Commission temporarily suspends trade of PixarBio stock

    Whale Imaging receives US FDA approval for G-arm B6 Duo

    SpinalCyte enrols first patient in human dermal fibroblasts phase I human...

    Early data demonstrate motor function improvement for spinal cord stem cell...

    Complete decontamination of robotic instruments “virtually impossible”

    minimally invasive surgery

    Minimally invasive surgery “markedly reduces” postoperative infection risk

    Implanet receives US and European marketing clearance for Jazz Frame

    Sixth INSPIRE patient improves ASIA score

    John Nosenzo appointed chief commercial officer of Bioventus

    Spinal cord stimulation reduces or stabilises opioid use among chronic pain...

    SI-Bone Ifuse

    Sacroiliac joint fixation with screws leads to more revision than fusion...

    Osseon receives new patent for bone augmentation system

    Zebra Medical Vision announces new algorithm to detect vertebral fractures

    New patient enrolled into Invivo Therapeutics INSPIRE study

    Spinal Elements Magnum+ achieves 96% solid fusion at seven months

    Precision Spine receives US FDA 510(k) clearance for ShurFit system

    Researchers determine algorithm for bionic hand treatment

    New Mexico Hospital joins Invivo’s INSPIRE study

    Zimmer Biomet to replace Robert Delp with Stuart Kleopfer as president...

    US FDA clears SpineGuard’s DSG third-party pedicle screw integration module

    First surgery with Amedica’s Taurus pedicle screw system successful

    First implantation using Vertebral Technologies’ Interfuse in Mexico a success

    Medicrea files FDA 510(k) submission for 3D-printed titanium spinal devices