Testing and Regulatory Landscape for Additively Manufactured Devices—An Orthopedic Innovators Q&A
Uncertainty in proper procedures has left orthopedic device manufacturers seeking answers.
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- Videobites
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Breast Cancer Survivor Living Near Medical Sterilization Plant Awarded $363M
Sterigenics vows to appeal the decision.Michael Barbella, Managing Editor 09.22.22
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Minding the Gap: How Harmonizing Quality Systems Pays Off
FDA issued a proposed rule to harmonize 21 CFR 820 with ISO 13485, which could save medical device companies $439 to $533 million over a decade.Dawn A. Lissy, Founder & President, Empirical 08.12.22
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The Case for Using Historical Control in Clinical Trial Design
Historical control refers to the use of data from past studies to estimate potential response to a placebo or standard care treatment among trial patients.Michael Coladonato and Lucas Tatem, MCRA 08.12.22
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Surgalign, RTI Settle Lawsuit Over OEM Biz Sale
The parties amended various agreements, including distribution agreements for spinal implants and biologics.Sam Brusco, Associate Editor 08.10.22
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Spine/Neurology
Nevro, Boston Scientific Settle IP Lawsuits
Lets Boston Scientific use the features and capabilities in its current line of products for frequencies below 1,500 Hz.Sam Brusco, Associate Editor 08.01.22
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Bracing/Prosthetics
Orthotic Brace Suppliers Convicted in $6.5M Fraud Scheme
Each defendant faces up to 55 years in prison.Sam Brusco, Associate Editor 05.18.22
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3-D Printing/Additive Mfg.
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Extremities
Extremity Medical Files Patent Suit Against Fusion Orthopedics
Company alleges infringement on patent for its intraosseous fixation platformSam Brusco, Associate Editor 04.29.22
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Extremities
Extremity Medical Files Patent Suit Against Zimmer Biomet, Nextremity
Firm alleges the companies infringed on a patent for its intraosseous fixation platform.Sam Brusco, Associate Editor 04.06.22
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Extremities
Treace Medical Files Patent Suit Against Fusion Orthopedics
Treace alleges multiple patent infringements related to its Lapiplasty 3D Bunion Correction system.Sam Brusco, Associate Editor 03.29.22
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Large Joint
Exactech Sued for Defective Hip Implant
Company is accused of misrepresenting its implant's polyethylene liner to have a lower wear rate.Sam Brusco, Associate Editor 02.16.22
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Advice for a Successful Medical Device Global Registration Plan
One of the most powerful communication tools available to those responsible for placing medical devices on the market is a global registration plan.Kara Budor, M.S., Senior Manager, International Regulatory Affairs, MCRA LLC 02.14.22
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Globus Accuses Medtronic and Former Employees of Stealing Business
Globus claims $2.5 million in business losses since defendants' resignations.Sam Brusco, Associate Editor 02.02.22
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Spine/Neurology
Nevro, Nalu Medical Settle SCS Patent Suit
Ongoing litigation dismissed; Nalu Medical no longer offering a high-frequency SCS therapy.PR Newswire 12.22.21
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Ship Hold Lifted for NuVasive's Titanium-Based Precice Devices
The company issued an updated field safety notice; IFU updated.Sam Brusco, Associate Editor 12.07.21
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AAOS Releases Pain Alleviation Clinical Practice Guidelines
Guidance is intended to minimize the use of opioids in the post-operative period for better patient outcomes.American Academy of Orthopaedic Surgeons 12.02.21
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MDR Finally Arrives, but Challenges Follow—2021 Year in Review
Resolving these challenges is critical to ensuring the MDR ship remains aloft and capable of fostering product innovation.Michael Barbella, Managing Editor 11.17.21
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FDA Regulatory Challenges for Antimicrobial Orthopedic Devices
Preventing and managing orthopedic-associated infections is one of the major challenges in orthopedic surgery.Mehdi Kazemzadeh-Narbat, Ph.D., Associate Director, Regulatory Affairs, MCRA LLC 11.17.21
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EU MDR Interpretation and Understanding—Devil in the Details
While the date to conform to all transitional requirements has passed, a new wave of scrutiny will arrive as organizations seek certification under the new MDR.Bryan Brosseau, Founder and Principal Consultant, Brosseau Consulting LLC 11.17.21
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Biden to Nominate Dr. Robert Califf for FDA Head
Califf brings nearly four decades of experience as a doctor, researcher, leader & public servant, including previous service as FDA commissioner.The White House 11.15.21
