FDA Addresses Custom Device Exemptions
FDA clarified changes to the Custom Device Exemption provision through a final guidance document....
Nov 07 2014,
Maxx Orthopedics’ First Successful Procedure with Libertas Hip Replacement
Pro-Dex Launches Engineering Services Division
Pro-Dex launched its Engineering Services Division, a new business line that recruits and places contract personnel and provides engineering and...
Nov 05 2014,
Oberg Costa Rica Receives ISO 13485 Certification
Oberg Costa Rica has achieved ISO 13485:2003 certification from the British Standards Institution....
Nov 05 2014,
Oxford Performance Materials and Yale to Develop 3D Printed Biomedical Technologies
Projects include the development of new PEKK-based cranial and facial devices that support direct tissue attachment and 3D printed PEKK...
Oct 29 2014,
Interstate Plastics Names Mark Courtright President
Courtright succeeds Galen Klokkevold as President of Interstate Plastics, a full-line distributor of plastic sheets, rods, tubes, films, bars and...
Oct 29 2014,
nanoMAG Signs License Agreement to Develop Bioabsorbable High-Strength Magnesium Alloy Implants
The collaboration is focused on achieving certain milestones, including regulatory approval for this new class of materials for use in...
Oct 13 2014,
CoorsTek Medical Integrates IMDS and C5 Medical Werks
CoorsTek Medical offers over 50 years of experience in product development and manufacturing of implantable medical devices, and also provides...
Oct 07 2014,
The Seven Phases of M&A
Given healthy balance sheets and cheap debt, large and mid-sized buyers are well positioned to pursue acquisition opportunities in 2018...
Oct 02 2014,
FDA Seeks 21st Century Agility with 510(k)s
FDA introduced several changes, including new initiatives to clarify the 510(k) submission process. How will these changes affect your device’s...
Oct 02 2014,
Can I Make, Use and Sell My Patented Invention? The Answer May Surprise You
Obtaining a patent does not always guarantee the ability to build and commercialize your invention. Follow these tips to avoid...
Oct 02 2014,
Surgeons Share Spine Device Trends and Challenges
Spine surgeons discuss trends that excite them, their biggest challenges when using devices and what they want you to know...
Oct 02 2014,
Zoning In with Dr. Vijay Goel
Dr. Vijay Goel, Co-Director of the Center for Disruptive Musculoskeletal Innovation (CDMI) shares the Center’s mission and initiatives to strengthen...
Oct 02 2014,
Strategic Orthopaedic-related 510(k) Update
See which orthopaedic companies recently received 510(k) clearances to market their products....
Oct 02 2014,
Accellent Unveils its New Brand Identity as Lake Region Medical
Accellent has commenced business under the name Lake Region Medical, following its acquisition of Lake Region Medical....
Sep 22 2014,
Talyrond 585 Metrology Tool Plays Key Role in Retrieved Hip Implant Analysis
Among the team's next steps is to develop the techniques utilized into standards that can be applied elsewhere in studying...
Sep 17 2014,