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Articles Tagged "clinical data"

American Academy of Orthopaedic Surgeons Launches Shoulder and Elbow Registry

by BONEZONE | Nov 2018

At launch, this AAOS registry will collect total shoulder arthroplasty procedures data. Rotator cuff repair and total elbow arthroplasty will follow in 2019.... Read more »

NAMSA Launches New Laboratory

by BONEZONE | Feb 2018

  The medical research organization is expanding access to accelerated product development and testing services.... Read more »

Invibio Makes Series of Investments to Drive Clinical Outcome Improvement

by BONEZONE | Nov 2017

The investments include faster time-to-market for devices through streamlined device-development strategies that consider the total costs of care.... Read more »

AAOS to Launch Orthopaedic Registries, Integrate With AJRR

by Robert Meyer | Nov 2017

As data plays an increasingly important role in orthopaedics, the American Academy of Orthopaedic Surgeons announced plans to create registries for a broad range of conditions and procedures.... Read more »

Reimbursement Tips: Four Things Payors Want

by BONEZONE | Jul 2017

The complexity of reimbursement may be great, but the burden may be lessened if you begin with the end in mind—and know what you’re up against—and make good choices throughout the process.... Read more »

One Answer to Your Postmarket Challenge: Planning

by Vicki Anastasi | Dec 2016

Planning goes a long way in moving from premarket to postmarket data collection. Vicki Anastasi, an OMTEC 2016 speaker, suggests the best way to start.... Read more »

CiToxLAB acquires AccelLAB Clinical Research Organization

by BONEZONE | Nov 2016

AccelLAB specializes in the pre-clinical assessment of new medical devices in orthopaedics and other specialties.... Read more »

Reimbursement in Spine: A NASS Priority

by Julie Vetalice | Sep 2016

In order for commercialization to succeed, everyone needs to be paid. Be proactive for you and your customers by making reimbursement a part of your development timeline.... Read more »

Cartiva Receives FDA PMA for Synthetic Cartilage Implant

by BONEZONE | Jul 2016

Cartiva received FDA Premarket Approval for the Synthetic Cartilage Implant to treat arthritis of the great toe. This is reported to be the first synthetic cartilage device and the first product in the forefoot to gain FDA approval.... Read more »

3 Points to Consider from the Long-Awaited EU Medical Device Regulations

by BONEZONE | Jul 2016

The new EU Medical Device Regulations could make it tougher for orthopaedic device manufacturers to do business in Europe.... Read more »

Building Evidence for Additive Manufacturing: What Questions Remain?

by BONEZONE | Jun 2016

In order for additive manufacturing to move from tinkering technology to widely-used process, it’s imperative to prove its long-term benefits. In May, researchers, surgeons, device companies and additive manufacturing suppliers gathered to develop guidelines to build data and support reimbursement... Read more »

AAOS Conversations Center on CJR and Future of Bundled Payments

by Carolyn LaWell | Mar 2016

The upcoming launch of the Comprehensive Care for Joint Replacement program fueled Annual Meeting conversations regarding the best response by device companies to bundled payment reimbursement models, including those that extend beyond joint reconstruction. Regulatory, R&D and supply chain folks... Read more »

Adaptive Designs Provide Clinical Trial Flexibility

by Hannah Corcoran | Dec 2015

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 »

Mobile Medical Apps Attract OEM, FDA Attention

by Prithul Bom, MBA, RAC | Jun 2015

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 »

U.S. Registry Offers New TJR Data

by BONEZONE | May 2015

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 »

CDRH Proposes Nationwide Postmarket Surveillance System

by BONEZONE | Apr 2015

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 »

CoorsTek Medical Integrates IMDS and C5 Medical Werks

by BONEZONE | Oct 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 »

Survey Finds Half of Surgeons Worldwide Unwilling to Use Generics

by BONEZONE | Jun 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 »

Zoning In with Robert Weigle

by BONEZONE | May 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 »