Regulatory & Legal
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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
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Large Joint
Conformis Settles Patent Dispute With Smith & Nephew
Conformis to receive $10.5 million for non-exclusive license to patient-specific instrument patents.Globe Newswire 09.17.18
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IlluminOss Medical Receives Clearance to Expand Clinical Indications in the U.S.
Secures FDA clearance for the treatment of traumatic, fragility, pathological, and impending fractures.Globe Newswire 09.13.18
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Acantha Wins $8.2 Million Patent Infringement Verdict Against DePuy Synthes
The patent in question covered an orthopedic implant assembly used to join bone segments.PR Newswire 08.24.18
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Extremities
KFx Medical Sues Stryker for Rotator Cuff Repair Patent Infringement
KFx successfully defended these patents versus Arthrex Inc. in 2015.Business Wire 08.17.18
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Effects of MEDDEV Revision 4 on Clinical Evaluation Reports (Part 2)
Whether writing a clinical evaluation report (CER) for a new device or updating one for an existing device, compliance with MEDDEV 2.7/1 Revision 4 requirements is integral. As part of the general planning associated with CERs, first perform a gap as…Jonathan Gimbel, Director, Regulatory and Quality Solutions LLC (R&Q) 08.15.18
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Innovation in the 510(k) Space: A Case for Incrementalism
Although the term “innovative technology” often evokes images of a breakthrough, radical discovery, or inventive cure-all, the certainty associated with incremental improvements to established, higher-risk technologies such as implantable…Samuel Pollard, Senior Regulatory Associate, Musculoskeletal Clinical Regulatory Advisors 08.15.18
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FDA’s Educational Opportunities Abound
As a former U.S. Food and Drug Administration (FDA) reviewer, I have spent a considerable amount of time learning the system from the “inside.” There are many avenues of training offered by the FDA, and if you know where to look, you may…Elizabeth O’Keeffe, Ph.D., Director, Engineering and Technical Services, Secure BioMed Evaluations 08.15.18
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Contract Manufacturing | Machining & Tooling
Empirical Machine Earns FDA Contract Manufacturer Designation
Colorado Springs company approved to craft medical devices in addition to prototyping, small-batch manufacturing.Empirical 06.14.18
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Extremities | Large Joint | Spine/Neurology | Trauma/Sports
FDA Initiates Device Development Challenge to Help Combat Opioid Crisis
The agency will work closely with selected applicants to accelerate product development.U.S. Food and Drug Administration 05.31.18
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Effects of MEDDEV Revision 4 on Clinical Evaluation Reports (Part 1)
The latest revision of MEDDEV 2.7/1 was published June 2016 and calls for substantial changes from revision 3. Updating clinical evaluation reports (CER) to meet the new requirements will require a major effort for most manufacturers selling in the E…Jonathan Gimbel, Director, Regulatory and Quality Solutions LLC (R&Q) 05.29.18
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Design | Research & Development
The Hidden Costs of Clinical Trial Agreement Negotiations
Negotiating can be a daunting task, often inducing anxiety in those without much practice. For many, it’s not a skill that develops naturally or easily. Graduate programs offer numerous courses aimed at preparing students for the necessary evil…Megan Florez, Compliance and Reimbursement Associate, Musculoskeletal Clinical Regulatory Advisors 05.29.18
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Modifications to a Cleared Device: Letter to File or New 510(k)?
Change is good, right? Most orthopedic manufacturers have been working under the ISO 13485 umbrella, which stresses the need for continuous improvement. Once a device is in commercial distribution, there are valuable lessons to be learned. Shouldn&rs…Linda Braddon, Ph.D., President and CEO, Secure BioMed Evaluations 05.29.18
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Doctor Charged With $240 Million Healthcare Fraud and International Money Laundering Scheme
Defendant allegedly administered chemotherapy and other toxic medications to arthritis patients based on false diagnosis.U.S. Department of Justice 05.18.18
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Spine/Neurology
SpinalCyte Applies to FDA to Expand Human Clinical Trial of CybroCell Dermal Fibroblasts
Company files investigational new drug application for degenerative disc disease cell therapy.Business Wire 05.17.18
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Biologics
FDA Seeks Permanent Injunctions Against Two Stem Cell Clinics
The two clinics allegedly marketed products without FDA approval.PR Newswire 05.11.18
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Sterilization Breach at Colorado Hospital Put Orthopedic Patients at Risk of HIV, Hepatitis
Implant or spine surgery patients who underwent procedures between July 21, 2016, and Feb. 20, 2018 are most at risk.Colorado Department of Health & Environment 04.05.18
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Your EU Medical Devices Regulation (MDR) Questions, Answered
The upcoming EU Medical Devices Regulation (MDR) changes are significant, potentially impacting device classification and the need for clinical data. It’s imperative organizations act now to meet these requirements in 2020 and beyond. Portfolio…Nancy Morrison, Director of Regulatory Affairs, Regulatory and Quality Solutions LLC (R&Q) 03.21.18
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Biologics
Cerapedics Receives FDA IDE Approval to Initiate Study of P-15L Bone Graft for TLIF Surgery
Pivotal study to evaluate next-generation synthetic small peptide technology compared to autograft in spine surgery.Cerapedics 03.16.18
