Press Releases

New White Paper Affirms FDA's 510(k) Change Guidance

The white paper includes a comprehensive analysis of the key laws and regulations, as well as previous guidance and other relevant documents, associated with the 510(k) process and FDA’s quality systems regulation (QSR).

AdvaMed Commends Nomination of Mike Froman as U.S. Trade Representative

“We congratulate Mike Froman, currently deputy national security advisor for international affairs, on his recent nomination to be U.S. Trade Representative and wish him a speedy Senate confirmation. We support the administration’s efforts to foster export growth and a level playing field for U.S.-based manufacturing."

Medical Technology Veterans Program Reports Successes, Eyes Expansion

In just one year, the MVP has received incredible support and recognition from the industry,” said Michael Minogue, Abiomed CEO and MVP chairman

AdvaMedDx Supports Diagnostics Payment Reform Legislation

We applaud Congressman Roskam for his leadership in recognizing the crucial role of diagnostics in patient care and the need to ensure continued innovation in this area..

Coalition of Small Business Innovators Launches

The Coalition of Small Business Innovators (CSBI) launches today with 15 organizations representing highly innovative pre-revenue small businesses, which employ millions of Americans in a broad array of U.S. industries.

Diane Biagianti Receives PwC Award for Leadership in Promoting Ethical Behavior in Medtech Industry

Diane Biagianti, vice president, chief responsibility officer at Edwards Lifesciences, today received the 2013 PwC Award for Leadership in the Advancement of Ethics in the Medical Device Industry, given at the sixth annual International Medtech Compliance Conference in Warsaw, Poland. 

Enhancements to Trans-Pacific Partnership Agreement Needed

"AdvaMed today submitted testimony to the Senate Finance Committee on the Trans-Pacific Partnership agreement, outlining specific objectives that AdvaMed believes should be addressed in the final agreement..."

AdvaMed Supports Confirmation of Marilyn Tavenner As Administrator of Centers for Medicare & Medicaid Services

"CMS is a critical agency, and it needs a permanent administrator to lead it during this time of major change. Her deep experience in health care and her record of respectfully working with all the major stakeholders make her an excellent choice to lead CMS..."

AdvaMed Expands, Strengthens Membership Function

"The Advanced Medical Technology Association (AdvaMed) today announced Jason Rupp has joined the association as vice president of business development."

Medical Technology Industry Calls for Regulatory Convergence In U.S.-E.U. Trade Deal

"As the single largest free trade agreement in history, TTIP will promote E.U. and U.S. international competitiveness, create jobs and grow our respective economies,” said Stephen J. Ubl, President and CEO of AdvaMed."

AdvaMed Reaction to the President's Proposed FY2014 Budget

“AdvaMed is carefully examining the Administration’s budget proposal for its impact on medical technology companies and the patients they serve..."

AdvaMed Praises OIG Warning on Physician-Owned Entities

“AdvaMed applauds the action taken today by the HHS Office of the Inspector General (OIG) in recognizing the inherent conflict-of-interest risks posed by physician-owned distributors (PODs)..."

Medical Device Manufacturing Coalition Applauds Passage of Medical Device Tax Repeal Amendment

The Medical Imaging & Technology Alliance (MITA), Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA) today applauded the adoption of an amendment to the Fiscal Year 2014 Senate Budget Resolution that expresses support for repeal of the medical device tax. The amendment passed with 79 votes.

Continuing Resolution Gives FDA Expanded User Fee Access, But Work Remains to Address Sequester

AdvaMed released the following statement praising Congress for approving a new continuing resolution (CR) that addresses FDA’s access to user fees paid by industry for the rest of the current federal fiscal year.

AdvaMed Partners with EucoMed and Alliance of Blood Operators on Blood Safety White Paper

AdvaMed, in conjunction with Eucomed and the Alliance of Blood Operators (ABO), today published a white paper on the value of harmonization efforts in blood device medical technology.

Manufacturers Make Case for Device Tax Repeal in Senate

“AdvaMed would like to thank the members of the Committee for holding today’s hearing on this crucial issue. We also commend Stephen L. Ferguson, chairman of The Cook Group, for testifying on behalf of companies across the country..."

AdvaMed "Doubles Down" on Device Tax Repeal

“This issue is critically important to companies large and small that already are living with the real-world harmful impact this tax is having – including layoffs, cuts in R&D and delayed expansion plans..."

AdvaMed Releases New Deficit Reduction Infographic

AdvaMed today released a new infographic featuring how repeated cuts & new taxes are affecting the MedTech industry. These costly new burdens & previous cuts to medtech threaten patient care, medical innovation, the economy, job creation, U.S. leadership and international competitiveness. 

Massachusetts Life Sciences Center and MassMEDIC Launch Medical Technology Mentoring and Employment Program for Local Veterans

"Thirty-two veterans were introduced to their industry mentors, who will help prepare participating veterans to enter the medical technology workforce."

AdvaMed Praises Bipartisan Efforts to Repeal Device Tax

Legislation introduced in the U.S. House of Representatives shows the growing bipartisan support for repealing the medical device tax, Advanced Medical Technology Association (AdvaMed) President and CEO Stephen J. Ubl said.

AdvaMed Unveils State-Based Competitiveness Agenda

Building on AdvaMed’s federal-level Competitiveness Agenda launched in 2011, the association’s new State Medical Technology Competitiveness Agenda outlines policy options states should adopt in order to foster an environment of growth and patient access to the latest in medical innovation.

New Survey Highlights Cost of Implementing Medical Device Tax

"Based on the survey, the device tax will cost the industry between $400 million and $667 million just to implement. Sixty-two percent of the companies said they would have to deal with the cost of the tax by imposing layoffs or reducing hiring."

AdvaMed Statement on the Fiscal Cliff and Device Tax

“The effort to repeal the medical device tax will continue. The passage of a scaled-back fiscal cliff package that did not address the medical device tax does not diminish the need to repeal the tax..."

IRS Final Device Tax Regulations Underscore Urgent Need for Action

"AdvaMed is carefully reviewing the regulations released today by the IRS. But regardless, Congress should act to address this $30 billion tax before it takes effect on January 1..."

Medical Device Tax Info Graphic

MDET Survey Results - Dec 2012

Leading Executives from Across the Country Urge Senate to Repeal the Device Tax

A broad coalition of medical technology companies, physician groups, venture capital firms and leading associations today submitted a letter to Senate leadership urging policymakers to repeal the onerous medical device tax that threatens U.S. jobs, medical innovation and patient care.

Leading Executives from Across the Country Urge Senate to Repeal the Device Tax

MedTech Prices Remain Consistently Low Over Two Decades

AdvaMed Leads Americas Competitiveness Forum Discussions to Promote Innovation and Ethics

MITA and AdvaMed Partner to Reduce Trade Barriers, Harmonize Medical Device Standards with China

AdvaMed/MTLI and UL EduNeering Introduce Certificate Program for Medical Technology Professionals