Oberg Medical Receives ISO 13485 Certification
Oberg Medical, a full-service Medical Device contract manufacturer providing implants, instruments and assemblies, proudly announces its recent certification to ISO...
Mar 13 2012,
Carpenter Technology Announces Plans for Emerging Technology Center
FDA and Industry Reach Agreement in Principle on Medical Device User Fees
Under a user fee program, industry agrees to pay fees to help fund a portion of the FDA’s device review...
Mar 12 2012,
Sharp Rise in Use of Bone Growth Factor for Spinal Fusion Surgery
Studies suggest that the use of bone morphogenetic protein (BMP) for spinal fusion has risen sharply over the past decade,...
Mar 12 2012,
Study Suggests that Nanodiamond Coatings are Safe for Implants
Researchers are investigating the ability of nanodiamond coatings to reduce wear in joints made of metal alloys....
Mar 12 2012,
New Technology to Track Movement and Durability of Implants in Hip and Knee Replacement Patients
A new tracking system developed by Halifax Biomedical is being used by Midwest Orthopaedics at Rush physicians to allow patients...
Mar 12 2012,
Do You Know Your Customer’s Boss?
Device companies, including those in orthopaedics, have traditionally recognized that their primary customer has been the physician. With the recent...
Mar 12 2012,
The Anatomy of a Warning Letter, Part One: A Primer
This is the first of two articles dealing with the dreaded Food & Drug Administration (FDA) Warning Letter. This first...
Mar 12 2012,
An Introduction to Patent Opinions
Whenever a medical device company develops a new product, process or technology, the topic of getting an “opinion” inevitably arises....
Mar 12 2012,
Strategic Orthopaedic-related 510(k) Update
The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first...
Mar 12 2012,
Executive Interview: Michael E. Miller, Chief Executive Officer, Orchid Orthopedic Solutions
Mike Miller shares Orchid's growth story....
Mar 12 2012,
Imaging Analytics and the Changing World of Orthopaedics
Harnessing the power of imaging analytics and incorporating them into a research study or product development program can yield benefits...
Mar 12 2012,
510(k) Clinical Data Requirements: Current Status and Considerations for Clinical Studies
In an effort to promote innovation while protecting the population at large, the US Food and Drug Administration (FDA) has...
Mar 12 2012,
Materialise Launches New Additive Manufacturing Automation & Control System
Materialise's new system helps AM professionals have control of each step in the work flow from the original order to...
Mar 09 2012,
Bradshaw Medical Announces New Utility Patent
Bradshaw Medical was issued utility patent US 8,127,454 B1 for their Rod Cutter, developed by Dr. Hua Gao, Vice President...
Mar 07 2012,
Rochling Engineering Plastics is ISO 13485:2003 Certified
Röchling strives to continuously improve its offerings and services and announced it is ISO 13485:2003 certified....
Mar 05 2012,