Regulatory & Legal
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Biologics
The ABCs of HCT/Ps
Navigating the complex regulatory pathway of human cell and tissue products.Lindsay Kleinwaks, Ph.D., Associate, Regulatory Affairs, MCRA 05.23.19
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Design | Software & Quality
Dominating the Competition with Digitization
Companies developing cutting-edge orthopedic devices need cutting-edge technology for their business processes. Whether a company focuses on finding new materials for implants, manufacturing better surgical instruments, or getting a new device throug…Bryant Headley, Customer Success Executive, MasterControl 05.23.19
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Biologics
ISASS Bone Grafting Policy Statement Features i-FACTOR Peptide Enhanced Bone Graft
Society states Cerapedics' drug-device combination technology is shown to be safe and effective as autograft replacement with clinical evidence.Cerapedics 04.29.19
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Software & Quality | Spine/Neurology | Trauma/Sports
Brainlab's Spine & Trauma 3D Navigation Software Recalled Over Misinterpretation Risk
Brainlab is recalling the Spine & Trauma 3D Navigation Software due to the potential for incorrect information to display during surgery.U.S. Food and Drug Administration 04.16.19
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Spine/Neurology
Spinal Implant Inspection Practices Established in New Standard
The new standard has broad appeal among different groups involved with surgical implants.ASTM International News 04.09.19
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ISO 14971 Update: What Changes Can Medical Device Manufacturers Expect?
ISO 14971 for medical device risk management is in the final stages of an important update slated for publication this year. While ISO has specifically said the intent of the revision isn’t to rework the risk management process, subtle changes…Tony Parise, Product Strategist—Life Sciences, ETQ 03.29.19
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Design
Regulatory Perspectives: Anatomy of a Medical Policy
Health insurance is a contract between a third party payer (insurer) and an individual to help cover medical and surgical expenses. The insured party pays a premium to the health insurer for this benefit. The rights and obligations of the insured and…Bonnie Clothier and Simran Madhani, MCRA 03.29.19
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FDA Commissioner Scott Gottlieb to Step Down
The 46-year-old physician, former venture capitalist, and drug consultant is due to resign in a month.Sam Brusco, Associate Editor 03.05.19
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Spine/Neurology
FDA Issues Guidance on Brain-Computer Interfaces for Paralysis or Amputee Patients
These devices can allow significantly greater mobility and independence for patients.Scott Gottlieb, M.D., Commissioner, U.S. Food and Drug Administration 02.25.19
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Spine/Neurology
Stimwave Responds to Nevro Patent Lawsuit
Stimwave maintains that the claims in the lawsuit are completely baseless, unfounded, and invalid.Business Wire 02.22.19
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Spine/Neurology
Nevro Files U.S. Patent Lawsuit Against Stimwave
Nevro asserts Stimwave is infringing patent's covering the Senza system and HF10 therapy.PR Newswire 02.15.19
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An Industry on the Defensive
It’s been a rough six months for the medtech industry. Nearly 200 days after it was first blindsided by a one-two punch of bad publicity from the damning Netflix documentary “The Bleeding Edge,” the sector remains firmly immersed…Michael Barbella, Managing Editor 02.13.19
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Design | Research & Development
Trial Master File: Paper or Electronic?
The Trial Master File (TMF) is the central location for all clinical trial documents. From the start of a clinical trial through its conclusion, the TMF contains and secures a variety of information such as signature pages, study logs, ethics committ…Anuradha Nagulapati, Clinical Research Associate, Musculoskeletal Clinical Regulatory Advisers 02.13.19
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Your 2019 ‘Regulatory Issues to Watch’ List
In 2018, one of the most prominent themes for the medical device industry had to be change. The year marked a continued transition for a number of regulatory initiatives as well as the emergence of several new challenges. In spite of how serious some…Sean Fenske, Editor-in-Chief 02.13.19
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Spine/Neurology
Alphatec Provides Update on NuVasive Patent Lawsuit
Several favorable developments were announced regarding the company's ongoing patent litigation.GlobeNewswire 02.11.19
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SIRAKOSS Receives CE Mark for Osteo3 Synthetic Bone Graft Substitute
The product consists of an inorganic matrix that is completely reabsorbed into the bone.Business Wire 02.04.19
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Spine/Neurology
Nuvectra Receives Full-Body MR-Conditional CE Mark Approval for Algovita
Approval broadens the company's global competitive advantage.Globe Newswire 02.01.19
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Large Joint
Dozens of U.S. Attorneys General Reach $120M Settlement With DePuy Over Hip Replacements
Authorities accuse DePuy of misleading patients about the longevity and efficacy of ASR XL and Pinnacle Ultamet hips.N.Y. Attorney General 01.22.19
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Aziyo’s CanGaroo Envelope Cleared for Expanded Use With Neurostimulator Devices
New indications include vagus nerve, deep brain and sacral nerve stimulators, as well as spinal cord neuromodulators.Business Wire 01.21.19
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Spine/Neurology
FDA Clears SpinalCyte IND Application for Universal Donor Cell Therapy to Treat Lower Back Pain
Acceptance of double blind degenerative disc disease data is strong signal for company’s development path.Business Wire 01.18.19
