Regulatory & Legal

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

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

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

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

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

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

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

Arthrex to Pay $16 Million to Resolve Kickback Allegations

Company was accused of paying Colorado surgeon to use and recommend its products.

U.S. Department of Justice 11.09.21

Spine/Neurology

Update on Nevro's Patent Litigation with Boston Scientific

Nevro infringed two Boston Scientific patents; jury awarded Boston Scientific $20 million.

PR Newswire 11.02.21

Spine/Neurology

Life Spine Responds to Globus IP Lawsuit

CEO Michael Butler: “We will vigorously defend our company against Globus’s claims.”

Business Wire 10.18.21

Spine/Neurology

Globus Sues Life Spine for Interbody Spacer IP Infringement

Alleges patent infringement related to Globus’ expandable interbody spacer technology.

GlobeNewswire 10.14.21

Large Joint

Settlement Approved in DePuy Synthes ASR Hip Implant Class Action

$15.5 million CDN settlement fund will be used to pay compensation.

PR Newswire 10.04.21

Early Regulatory Strategy: Streamlining the Path to Market

Planning for a regulatory submission entails consideration of numerous requirements beyond simply the content and required elements of the application.

Bryan Brosseau, Founder and Principal Consultant, Brosseau Consulting LLC 09.14.21

Five Lessons Learned Since MDR’s Implementation

The EU’s MDR took effect May 26, whereby all manufacturers must be in compliance if they intend to sell in the EU.

Hannah Irwin and Michelle McDonough, MS, MCRA 08.17.21

Spine/Neurology

Potential Concerns with NuVasive MAGEC System Implants

Potential mechanical failures and concerns about tissue incompatibility.

U.S. Food and Drug Administration 07.16.21

Conformis Settles Patent Litigation with Stryker

Companies settle Wright Medical litigation related to patient-specific instruments for use with shoulder implants.

Globe Newswire 07.07.21

When Is Digital Health Technology Regulated?

Whether you’re a startup or a well-established manufacturer, it can be challenging to determine if the software you’re developing needs FDA oversight.

Nikki Batista, Director, Digital Health Regulatory Affairs, MCRA LLC 05.17.21

Spine/Neurology