Regulatory & Legal

Spine/Neurology

NASS Recommends Basivertebral Nerve Ablation as a Low Back Pain Treatment

The policy proactively defines appropriate coverage positions based on the effectiveness of BVN ablation as a treatment option.
Michael Barbella, Managing Editor 05.15.23
Biocompatibility & Testing

The MDR Delay’s Impact on Regulatory and Testing—An Orthopedic Innovators Q&A

While the recent MDR delay gives companies some breathing room, it should not stall their effort in ensuring their products remain compliant for the EU.

Sponsored Released By Nelson Laboratories LLC 03.23.23
Extremities

Treace Medical, Fusion Ortho Settle IP Lawsuit

The terms of the settlement were not released.
Sam Brusco, Associate Editor 03.03.23
AAOS Updates CPG for Surgical Management of Knee Osteoarthritis

Updated guideline offers the latest in evidence-based research to improve surgical success and reduce complications, postoperative pain.
Michael Barbella, Managing Editor 03.01.23
Conformis, Bodycad Laboratories Settle Patent Litigation

Settlement resolves ongoing dispute that began in June 2021.
Michael Barbella, Managing Editor 02.16.23
3-D Printing/Additive Mfg. | Instruments

Reflections on 2022 and What’s Ahead for Orthopedic Technology: ODT Sounding Board

Several members of the ODT editorial advisory board share their thoughts on the headlines of 2022 and what’s coming in 2023.
Online Exclusives Sean Fenske, Editor-in-Chief 12.01.22
Breast Cancer Survivor Living Near Medical Sterilization Plant Awarded $363M

Sterigenics vows to appeal the decision.
Michael Barbella, Managing Editor 09.22.22
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
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
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
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
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
3-D Printing/Additive Mfg.

Testing and Regulatory Landscape for Additively Manufactured Devices—An Orthopedic Innovators Q&A

Uncertainty in proper procedures has left orthopedic device manufacturers seeking answers.

Sponsored Released By Empirical Technologies 05.10.22
Extremities

Extremity Medical Files Patent Suit Against Fusion Orthopedics

Company alleges infringement on patent for its intraosseous fixation platform
Sam Brusco, Associate Editor 04.29.22
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
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
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
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
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
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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