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Articles Tagged "device company"

FDA 510(k) Insights: March Clearance Highlights

by BONEZONE | Apr 2017

Strategic FDA 510(k)s released in March 2017 include a cannula from AJU Pharm, Bodycad's uni knee, a new company from Surgical Frontiers' portfolio and a revision system from MicroPort Orthopedics.... Read more »

Additive Manufacturing Experts Talk Quality

by BONEZONE | Dec 2016

Talk of the promise of additive manufacturing and 3D printing often centers on aspects of cost, speed, advanced designs, clinical outcomes. With any technology used in our highly-regulated, patient-facing industry, quality—of the process, of the machine, of the finished product, of the knowledge o... Read more »

Unique Device Identification (UDI): Many Questions Remain

by Karen Conway | Dec 2014

FDA issued its final rule requiring medical device manufacturers to assign and label products with UDIs more than a year ago. However, many questions remain for orthopaedic and spine manufacturers.... Read more »

Greater Memphis Medical Device Council Forms to Support Industry Health

by BONEZONE | Jul 2014

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Industry Outlook Remains Positive Despite Excise Tax

by BONEZONE | Apr 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Develop Orthopaedic Implants Faster Through Auditing

by Robert Packard | Feb 2013

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

The Global Orthopaedic Supplier Market

by Julie A. Vetalice | Dec 2012

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Sector Snapshot: The Orthopaedic OEM and Supplier Markets

by BONEZONE | Dec 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Funding Activity in Orthopaedics and Spine

by BONEZONE | Dec 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Strategic Orthopaedic-related 510(k) Update

by BONEZONE | Dec 2011

The following companies recently received strategic FDA 510(k) clearances for devices in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk. Algea TherapiesAffirm Vertebral Compression Fracture System... Read more »

Merger and Acquisition Activity in Orthopaedics and Spine

by BONEZONE | Dec 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

Challenges in the Supply Chain

by BONEZONE | Dec 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

BSI Enhances its Medical Device Training Curriculum with RABQSA

by BONEZONE | Sep 2011

RABQSA International (RABQSA) and BSI Group America have co-developed an innovative Medical Devices training curriculum, created for individuals wishing either to become trained to audit to the Medical Devices Standard (ISO 13485) or simply to understand the requirements of a medical devices quality... Read more »

1Q11 Company Financials: Orthopaedic and Spine

by BONEZONE | Aug 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

2010 Company Financials: Orthopaedic and Spine

by BONEZONE | Jun 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »

2010 Company Financials: Orthopaedic and Spine

by BONEZONE | Mar 2011

Adaptive designs have emerged as an attractive alternative to traditional clinical studies due to the potential to reduce resources, time and costs. However, several critical components must be considered to determine whether such a trial design is a fit for you.... Read more »