Where are companies best advised to obtain their clinical data, the EU or the US and why?
What the FDA wants you to know when conducting PMA clinical trials outside of the United States
Regulatory Challenges in Getting Total Disc Replacements Onto the Market in an Era of Increased Food and Drug Administration Scrutiny
Coverage of IDE Clinical Trial Costs: Navigating the Medicare Maze
A Historical Framework for Accountable Care Organizations: Will CMS Meet Its Long-Term Goals with this Initiative?
Tools, Tips and solutions for coding and billing community.
Device firms with well-planned reimbursement strategies position themselves to secure market share and sales they might otherwise have lost.
The year 2009 signals change within the U.S. healthcare framework—from the inauguration of the 44th president, Barack Obama, to sweeping changes in Congress.
How Medicare Rule Would Impact
Orthopedic Technology Firms
Comparative effectiveness research examines clinical outcomes, or the clinical effectiveness, of alternative therapies for the same condition.
The Centers for Medicare and Medicaid Services (CMS) recently released several proposed and final rules outlining
Completing a pivotal trial may be the biggest challenge developers of artificial discs face as the market for the devices gets more crowded, say consultants
Pending patent litigation between Medtronic and Spine Solutions could shape the artificial disc
In recent years, the issue of medical technology reimbursement has moved from passive discussion to the
Data needed for a successful regulatory approval does not necessarily encompass the data needed for successful
Non-fusion spinal implant maker Paradigm Spine decided t o spend 15%-20% more than needed to satisfy FDA's data
Number 3, 2007
Food and drug law journal. Analyzing the Laws, Regulations, and Policies
Affecting FDA-Regulated Products
FDA Ortho Panel Recommends STAR Ankle PMA Approval—
With Elephant in the Room
An independent panel of reviewers voted unanimously Tuesday to
recommend that federal medical regulators approve the first artificial replacement for failing disks in