In’Tech Medical Acquires Turner Medical
In'Tech Medical, a Europe-based manufacturer of orthopaedic instruments, acquired contract manufacturer Turner Medical, yielding the world's reportedly largest provider of...
Jul 02 2015,
Zimmer Biomet Gains FDA Approval for Tether Scoliosis Treatment
Secant Medical Moves Corporate Headquarters to Telford
Secant Medical has been investing heavily in the regenerative medicine field by enhancing its operations and new biomaterials platform technology...
Jul 01 2015,
New UDI Draft Guidance Addresses Direct Marking of Reprocessed Devices
FDA’s most recent UDI draft guidance, Unique Device Identification: Direct Marking of Devices, addresses common questions posed by labelers preparing...
Jul 01 2015,
Purchasing Controls: Draft the Best Supplier Quality Agreement
Quality agreements are an essential management tool to prevent supply chain problems. The best contracts clearly define the extent of...
Jul 01 2015,
Regulatory Expert Builds Web Tool to Assist Companies with 510(k)s
Frustrated with FDA’s 510(k) search function, Eric Eggers created kBLASTER to help companies simplify and speed their 510(k) submissions....
Jul 01 2015,
How to Proceed When a Testing Standard Doesn’t Exist
Orthopaedic device innovation is evolving, and there will be gaps in device testing standards and guidance. Here are three proactive...
Jul 01 2015,
Getting Lean: Strive for Built-in-Quality
During his OMTEC presentation, Joe Mazzeo pinpointed the principles necessary to build a culture of inherent quality, stressing strong leadership...
Jul 01 2015,
Zimmer Closes Biomet Acquisition
Zimmer has completed its acquisition of Biomet to form the world's second-largest orthopaedic device company, with estimated market...
Jun 24 2015,
Formation of Restoration Medical Polymers, LLC, with Micropulse, Inc.
Restoration Medical Polymers has formed to offer materials and process development services to customers seeking assistance in the medical polymer...
Jun 18 2015,
FDA Outlines Stance on ex-U.S. Clinical Data
In a recent draft guidance, FDA describes what device companies should consider when submitting OUS clinical data for regulatory approval...
Jun 09 2015,
FDA Launches Searchable UDI Database
FDA recently announced the launch of AccessGUDID, a website that allows users to search and download information on devices that...
Jun 09 2015,
Globus Medical Completes Acquisition of Supplier Branch Medical
The spine company, which currently uses Branch to manufacture about a quarter of its products, plans to boost that number...
Jun 09 2015,
Mobile Medical Apps Attract OEM, FDA Attention
Mobile communication devices are radically changing the way we think and make decisions about our healthcare. Manufacturers developing medical mobile...
Jun 09 2015,
OEM Executives Offer Perspective on Robotics, Orthobiologics and Hospital Changes
In anticipation of OMTEC, we highlight discussion between the keynote speakers on the latest technologies and market players. After presenting...
Jun 09 2015,
Boston Centerless Offering Skilled Material® to Improve CNC Swiss Productivity
The reliability and consistency of Skilled Material® bars from Boston Centerless address challenges faced by CNC machine shops in the...
May 27 2015,