Readers underwhelmed by FDA’s 510(k) efforts
A MedicalDesign.com Reader Poll shows that about 3 out of 4 respondents are disappointed with FDA...
FDA clears first-ever antiviral surgical mask
BioFriend BioMasks are the first-ever antimicrobial surgical facemasks. Developed by Filligent Limited, Hong Kong, the masks recently received FDA approval...
First-ever MPC and AdvaMed 2011 are musts
Medical Design’s first-ever Medical Prototyping Conference (MPC) is fast approaching, and if you have anything at all to do with the design and development of medical devices you and your colleagues really need to make plans to be in Minneapolis September 7-8...
AdvaMed to IRS: Don’t double tax combination products, kits
Medical technology association AdvaMed has sent additional comments to the IRS regarding the taxation of certain types of devices including combination products, kits, and rented or leased items...
Congress urged to advance “Competitiveness Agenda”
More than 20 US leading medtech executives went to Capitol Hill last week to urge Congress to help preserve the industry’s competitiveness and global leadership in the development of new medical devices and diagnostics....
VdE initiative to boost US bioinnovation
Value-driven engineering (VdE) is the focal point of a plan developed by a group of leading biomedical organizations that assembled last March at A Safe Haven Summit in Washington, DC...
Industry and VC groups to Congress: FDA needs a better balance between risks and benefits
There is most certainly a better way to handle medical device approvals in the US. That was the consensus of testimony to the US House of Representatives Committee on Oversight and Government Reform hearing June 2....
FDA’s Shuren responds to latest 510(k) survey with action items
Findings from an industrywide 510(k) study conducted by researchers at Northwestern University and funded by Washington, DC-based InHealth (Institute for Health Technology Studies), are significant, yet hardly surprising....
European regulators and industry to continue focus on international harmonization
The European Diagnostic Manufacturers Association (EDMA) and Eucomed, the European medical technology industry association, confirmed their commitment to continuing to collaborate on the development of robust, globally consistent regulatory systems that will facilitate access to innovative, safe, effective, and high-quality, clinically beneficial medical technologies for the benefit of patients worldwide. ...
Nine medtech associations join to advance ethical behavior globally
The leaders from nine medical technology associations worldwide have signed the “Global Compliance Statement on Interactions Between Medical Technology Companies and Healthcare Professionals (HCPs),” in an effort to further advance ethical behavior globally....
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