Orthopedic Devices
AxioMed receives CE mark approval for Freedom Cervical Disc
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AxioMed Spine has received CE mark approval for its elastomeric total spinal disc replacement device, Freedom Cervical Disc.
Specialty Devices > Orthopedic Devices > News
AxioMed Spine has received CE mark approval for its elastomeric total spinal disc replacement device, Freedom Cervical Disc.
Specialty Devices > Orthopedic Devices > News
The Orthopaedic Implant Company introduces Pedicle Screw system
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The Orthopaedic Implant Company (OIC), a developer of orthopaedic implants, has introduced Pedicle Screw system.
Specialty Devices > Orthopedic Devices > News Intelligent Orthopaedics, Internal Fixation in STORM distribution agreement By
Intelligent Orthopaedics (IO) has entered into an agreement to distribute Internal Fixation Systems' Staffordshire Orthopaedic Reduction Machine (STORM).
Specialty Devices > Orthopedic Devices > News
The Orthopaedic Implant Company (OIC), a developer of orthopaedic implants, has introduced Pedicle Screw system.
Specialty Devices > Orthopedic Devices > News Intelligent Orthopaedics, Internal Fixation in STORM distribution agreement By
Intelligent Orthopaedics (IO) has entered into an agreement to distribute Internal Fixation Systems' Staffordshire Orthopaedic Reduction Machine (STORM).
Specialty Devices > Orthopedic Devices > News
Latest Orthopedic Devices News and Insight
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Bacterin signs three-year national GPO contract with Novation
Bacterin International has signed a third national group purchasing organization (GPO) contract, a three-year agreement with Novation.
Specialty Devices > Orthopedic Devices > News
Specialty Devices > Orthopedic Devices > News
BioElectronics completes ActiPatch trial
BioElectronics has completed a double blind, randomized, placebo controlled trial on delayed muscle onset soreness using its ActiPatch product.
Specialty Devices > Orthopedic Devices > News
Specialty Devices > Orthopedic Devices > News
OrthoSensor secures additional $15m in Series B financing
OrthoSensor, a provider of intelligent orthopedics, has secured an additional $15m in Series B preferred stock financing round.
Specialty Devices > Orthopedic Devices > News
Specialty Devices > Orthopedic Devices > News
BfArM Dialog Meeting in Bonn
Two (2) years have passed since the introduction of the German Medical Device Law Amendment (21.03.2010). This was a major legal change that re‐shaped the German regulatory medical device landscape on many levels. Before that, starting a clinical study in Germany required only an Ethics Committee approval and a relatively simple local authority notification.
Specialty Devices > Orthopedic Devices > Press Releases
Specialty Devices > Orthopedic Devices > Press Releases
Is FDA Changing Its Philosophy on Sponsor Monitoring of Clinical Trials?
Does publication of its Draft Industry Guidance, Oversight of Clinical Investigations—A Risk‐Based Approach to Monitoring, signal a shift in FDA’s philosophy of the monitoring of clinical studies for device approvals?
Specialty Devices > Orthopedic Devices > Press Releases
Specialty Devices > Orthopedic Devices > Press Releases
Taxes and the Medical Device Industry
France has raised its tax on medtech companies from 0.25% to 0.29% of sales. This tax is no longer payable to AFSAPPS (now known as ANSM) but to the national health insurance body.
Specialty Devices > Orthopedic Devices > Press Releases
Specialty Devices > Orthopedic Devices > Press Releases
Transparency Trends at FDA: Insight into Risk– Benefit Determinations for PMAs and DeNovo 510k Classifications
Unexpected guidance? FDA’s recent release of, Factors to Consider When Making Benefit‐Risk Determinations in Medical Device Pre‐Market Approval and De Novo Classifications, marks a milestone in FDA guidance documents. Clarity is the message FDA has chosen to emphasize in this final guidance document.
Specialty Devices > Orthopedic Devices > Press Releases
Specialty Devices > Orthopedic Devices > Press Releases
Hanger completes patient enrollment for Instride IDE clinical trial
Hanger Orthopedic Group has completed enrolling patients for its Instride investigational device exemption (IDE) clinical trial.
Specialty Devices > Orthopedic Devices > News
Specialty Devices > Orthopedic Devices > News
FDA clears Angioslide new Proteus device
The US Food and Drug Administration (FDA) has cleared Angioslide's new Proteus device for treating peripheral artery disease in below the knee (BTK) vasculature.
Specialty Devices > Orthopedic Devices > News
Specialty Devices > Orthopedic Devices > News
Tiger Flexible Motor Control: 1-2 axes, 450 W/motor, Microprocessor-based Control
Download the attached PDF to find out more.
Specialty Devices > Orthopedic Devices > White Papers
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