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In a recent draft guidance, FDA describes what device companies should consider when submitting OUS clinical data for regulatory approval...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,
Knee Replacement Launches: ATTUNE Cementless, Persona Revision and Sterizo Total Knee
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,
Orchid Opens New Facility in Pune, India
Orchid India's new Pune facility will focus on precision machined parts, expanding capabilities gradually to serve local, regional and global...
May 20 2015,
Bradshaw Medical Announces New Patent
Bradshaw Medical was issued US Patent No. 8,985,593 B1 for their Self-Locking Internal Adapter for D-Shaped Orthopedic Adjustment Tools. This...
May 19 2015,
C&A Incorporates Additive Manufacturing Technology to Grow Titanium Production Parts
C&A Tool Engineering added two new EOS M290 machines designed to produce Additive Manufacturing parts in titanium. The EOS M...
May 18 2015,
Precision Engineered Products Acquires Trigon
Precision Engineered Products acquired Trigon, a specialist in design, engineering, manufacturing and assembly services for orthopaedic products....
May 13 2015,
Training Your IP Police Force to Catch Infringement
It is critical for all companies to establish and properly train their own IP police force to enforce their own...
May 12 2015,
New Supply Chain Models Shift Resources from Device Makers to 3PLs
Orthopaedic device manufacturers can benefit from outsourcing services such as inventory management, warehousing, order processing and shipping, thus freeing up...
May 12 2015,
Product Spotlight: Arthroscopy and Soft Tissue Repair
Here, we present highlights from a variety of technologies cleared and launched during 2014 and 2015 across traditional and biologic...
May 12 2015,
Zoning In With Richard Randall
ichard Randall, recently appointed CEO of OMNI, plans to drive growth by expanding the company’s robotics portfolio and targeting new...
May 12 2015,
Big Changes in ISO 13485:2015?
On February 5, 2015, a second draft of ISO 13485 was released to the world for comment. How will new...
May 12 2015,