How to Incorporate Software Validation in Your Device Design and Quality Processes
In our latest Ask the Expert article, we answer how software validation fits with your SOPs for design validation and...
May 25 2020,
Competitive Landscape
FDA 510(k) Recap: Line Extensions and Small Companies
FDA's orthopedic panel cleared 49 products in April, we’ve chosen updates from Arthrex, Medacta, OrthAlign, Akros Medical and Subchondral Solutions....
May 25 2020,
OEMs and Suppliers Share Best Practices in Collaborative Forecasting
We convened a conversation to discuss how companies utilize forecasts and ways to gain greater accuracy. ...
May 12 2020,
COVID-19 Amplifies Forecasting Challenges for OEMs and Suppliers
Management from Zimmer Biomet, Wright Medical, Autocam Medical, NN Life Sciences and SITES Medical share how they're responding to supply...
May 12 2020,
How Will FDA’s CDRH Reorganization Impact Me?
The goal of the CDRH reorganization was to drive operational efficiencies. Some organizations will feel the impacts of changes more...
May 12 2020,
What Does the Next Generation of Total Ankles Need?
Preoperative planning, surgical instrumentation and bony ingrowth are advancements that surgeon Alan Davis, M.D., says are a must for future...
May 12 2020,
Embody Raises Funds for Soft Tissue Repair Technology
Funds will support commercial launch and postmarket clinical studies of the Tapestry system to treat serious tendon and ligament injuries....
May 11 2020,
M&A Update: Stryker and Wright Medical, RTI Surgical, ATEC
Orthopedic M&A activity is challenged by the COVID-19 environment. We review earlier announced acquisitions and provide thoughts on future activity. ...
May 07 2020,
Integrated Endoscopy Solves Arthroscope Design Challenges with NUVIS
The NUVIS system reduces wires and equipment with a single-use, HD arthroscope....
Apr 29 2020,
COVID-19 Heightens Focus on the Cost of Orthopedic Care
In this video interview with Peter Althausen, M.D., we discuss how COVID-19 will change care delivery, including shifting procedures to...
Apr 27 2020,
FDA 510(k) Recap: Joint Replacement Updates and Line Extensions
To date in 2020, joint replacement players like Arthrex, Conformis, DePuy Synthes, Medacta, Zimmer Biomet and others have gained FDA...
Apr 21 2020,
EU MDR Postponement Clears Another Hurdle
The European Parliament voted to postpone MDR until 2021. The regulation's postponement now moves to its final steps. ...
Apr 21 2020,
OrthoSensor Gains 510(k) Alignment Clearance for VERASENSE for use with Zimmer Biomet’s Persona Knee
VERASENSE is a sensor-assisted device used with leading knee implant systems during primary and revision total knee procedures....
Apr 20 2020,
FDA Approves Centinel Spine’s Two-Level prodisc L for Total Disc Replacement
prodisc L is the only total disc replacement system in the U.S. approved for two-level use in the lumbar spine....
Apr 17 2020,
How To Build A More Resilient Supply Chain Post COVID-19
Dr. Vinod Dasa highlights how automating the hospital-device company supply chain will eliminate waste....
Apr 08 2020,