Regulatory & Legal
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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
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OrthoPediatrics Files Sanctions Motion Against Former Employee & WishBone Medical
Underlying lawsuit alleges Robert von Seggern stole OrthoPediatrics’ trade secrets and confidential information, then turned those over to WishBone Medical.GlobeNewswire 01.03.19
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Reworked Tax Relief Package Could Delay Medical Device Tax Five More Years
The House Ways and Means Committee introduced the legislation in response to urgent relief from recent natural disasters.Sam Brusco, Associate Editor 12.11.18
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Large Joint
Past Dues: A Review of Industry in 2018
The industry confronted old ghosts in 2018 as it defended itself against a documentary and crammed for regulatory changes.Michael Barbella, Managing Editor 11.30.18
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MDSAP Audits Update: Progress, Challenges, and a Cost Reduction Case Study
The Medical Device Single Audit Program (MDSAP) is growing fast, with 3,629 sites now participating, as compared to just 788 at the end of 2017. Part of this explosive growth stems from the fact that Canada will require manufacturers to comply wit…Anthony Parise, Product Strategist—Life Sciences, ETQ 11.30.18
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Data Monitoring Committees: Making DMCs Work for Your Study
The use of independent data monitoring committees is becoming increasingly prevalent in the U.S. medtech industry. The FDA outlines these groups and their operation in a 12-year-old guidance due to expire at the end of this year. However, the composi…Margeaux Rogers, Senior Associate, Regulatory Affairs, Musculoskeletal Clinical Regulatory Advisers LLC 11.30.18
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Top 10 Findings from a Warning Letter Analysis
When I first started out in medtech, I did not have a good appreciation for quality systems. I was working as an engineer at the time, and I found quality systems quite a nuisance because any change I proposed was either restricted or not allowed due…Linda Braddon, Ph.D., President and CEO, Secure BioMed Evaluations 11.30.18
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Spine/Neurology
Zimmer Biomet Recalls Spinal Fusion and Long Bone Stimulators
Certain lots were recalled due to lack of adequate validation and controls to ensure product cleanliness.U.S. Food and Drug Administration 11.29.18
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FDA Plans to Modernize 510(k) Program
Agency releases statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., director of the CDRH.U.S. Food and Drug Administration 11.26.18
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Spine/Neurology
Zimmer Biomet Spine Announces FDA Approval of Mobi-C Cervical Disc Labeling Extension
Seven-year results demonstrate clinical superiority of Mobi-C two-level cervical total disc replacement procedures.Zimmer Biomet Holdings Inc. 09.28.18
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Getting Started on the Right Foot: Initiating Orthopedic Clinical Trials
Initiating an orthopedic clinical trial (OCT) is an exciting milestone for companies as years of pre-clinical testing and conversations with the U.S. Food and Drug Administration (FDA) finally come to fruition. Focusing on specific elements of the st…Bhavana Shivakumar , Clinical Research Associate, Musculoskeletal Clinical Regulatory Advisers LLC 09.19.18
