Regulatory & Legal
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Breaking News | Large Joint | OEM News | Regulatory & Legal
First U.S. Lawsuit Filed Against DePuy-Synthes for Attune Knee Replacement Failure
9 prominent orthopedic surgeons reported they have encountered an unusually high-rate of premature failures of the system.PR Newswire 09.18.17
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Bracing/Prosthetics | Quality, Recalls & Risk | Regulatory & Legal | Software & Quality | Supplier & Contract Mfg.
PLM Software Offers a Step Forward in Prosthetics Development
BionX meets time-to-market, compliance, and efficiency goals to produce the world’s only active prosthetic foot.Online Exclusives Alaine Portnoy, Senior Marketing Manager, Omnify Software 09.06.17
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Regulatory & Legal
Comparing cGMP Pharma vs. Device: Subpart A – General Provisions
Since they are both part of the healthcare industry, you’d think pharmaceutical and medical device companies would have a better understanding of each other’s current Good Manufacturing Practices (cGMP) requirements. Think again. Despite…James A. Dunning, Owner, QPC Services LLC 08.15.17
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Breaking News | Regulatory & Legal | Spine/Neurology
Australian Regulators Approve Providence Medical's Tissue-Sparing Cervical Fusion Products
DTRAX line of devices and instruments are designed to increase procedural efficiency, improve clinical outcomes.PR Newswire 07.26.17
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Breaking News | Regulatory & Legal
Anika Announces Regulatory Approval for MONOVISC in India
Product is already commercially available in the United States, Canada, and Europe.Business Wire 07.25.17
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Breaking News | OEM News | Regulatory & Legal | Spine/Neurology
Vertera Spine's Porous Interbody Fusion Device Receives New CMS ICD-10 Code
COHERE Cervical Interbody Fusion Device is the only product approved for use with the new code.PR Newswire 06.15.17
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Breaking News | International | OEM News | Regulatory & Legal
Zimmer Biomet Resolves FDA Warning Letter for China Facility
Warning Letter related to Zhejiang, China manufacturing facility has been closed out.PR Newswire 06.15.17
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Biologics | Regulatory & Legal | Trauma/Sports
Seeing Pain Relief in a New (Infrared) Light
Welcome to another installment of technology-based opioid alternatives to treat orthopedic pain. This one’s a bit on the lighter side (joke to be explained in due course), and features some empirical evidence, as I was able to test this device…Sam Brusco, Associate Editor 05.19.17
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Quality, Recalls & Risk | Regulatory & Legal
Mock Trial: Outsourcing to Prepare for Your Class III Premarket Panel
For a company navigating a Class III medical device’s path to market, the U.S. Food and Drug Administration (FDA) panel presentation is the make-or-break point. That’s the day to present a case to convince the FDA the device—for whi…Dawn A. Lissy, President & Founder, Empirical 05.19.17
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Regulatory & Legal
Current Good Manufacturing Practices: Pharma vs. Device
After years of working in and consulting for pharmaceutical and medical device companies on quality and regulatory matters, I am still somewhat surprised by the difficulty both industries have in understanding the other’s Current Good Manufactu…James A. Dunning, Owner, QPC Services LLC 05.19.17
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Regulatory & Legal
Enhanced CE Mark Requirements for Clinical Evaluation Reports
The European Union’s requirements for CE marking significantly changed with last summer’s fourth official revision of MEDDEV 2.7/1. From the standpoint of those who ensure a project’s documents are compliant and properly submitted f…Linda Braddon, Ph.D., President and CEO, Secure BioMed Evaluations 05.19.17
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Breaking News | Regulatory & Legal
New 510(k) Approach Would Leverage FDA Objective Criteria
AdvaMed president issues statement in support of new legislation.Advanced Medical Technology Association 05.18.17
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Breaking News | People | Regulatory & Legal
Industry Offers Support for Gottlieb Confirmation
Dr. Gottlieb previously served as the FDA’s deputy commissioner for medical and scientific affairs.Sean Fenske, Editor 05.10.17
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Breaking News | Regulatory & Legal
Amedica Given Clearance to Sell its Valeo Silicon Nitride Spinal Implants in Australia
Australian surgeons and engineers were the first to synthesize reaction-bonded silicon nitride 30 years ago.Marketwired 04.25.17
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Breaking News | Regulatory & Legal
Senate Bill Would Improve Medicare LCD Process
Bipartisan legislation is designed to ensure Medicare beneficiary access to needed medical technologies and services.Advanced Medical Technology Association (AdvaMed) 03.31.17
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Breaking News | Regulatory & Legal | Spine/Neurology
ASTM Standard Could Support Preclinical Testing for Disc Replacements
Ultimately, the proposed standard could improve the longevity and clinical performance of devices.ASTM International 03.24.17
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Breaking News | Biocompatibility & Testing | Instruments, Cases & Trays | Regulatory & Legal
ASTM Guide Supports Cleaning Protocols for Reusable Medical Devices
The standard also provides procedures for selecting the appropriate test soil for different kinds of devices.ASTM International 03.21.17
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Breaking News | Regulatory & Legal | Software & Quality
Senate Bill Would Modernize FDA MedTech Inspection Process
This legislation will lead to a higher level of patient safety and more efficient use of inspector time and effort.Advanced Medical Technology Association (AdvaMed) 02.16.17
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Breaking News | Large Joint | Regulatory & Legal
New ASTM Medical Standard Could Help with Knee Repair
Proposed standard would support potential for small “scaffolds” to regrow tissue around knee joint after a meniscus injury.ASTMu00a0 01.23.17
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Breaking News | Regulatory & Legal
Orthofix Reaches Final Resolution of SEC Investigations
Relates to accounting errors and an anti-bribery matter involving the Company’s Brazilian subsidiary.Business Wire 01.19.17
