Netflix’s ‘The Bleeding Edge’ blasts medtech & FDA

Netflix has unleashed a blistering indictment of the medical device industry, the FDA and doctors who accept money from medtech in its new documentary, ‘The Bleeding Edge,’ released today. The film depicts people who have suffered injuries and/or illnesses following placement of Bayer’s Essure sterilization device, Johnson & Johnson’s vaginal mesh, various manufacturers’ metal artificial

House votes (again) to repeal medical device tax

The House voted 283 to 132 this week to repeal the 2.3% tax levied upon medical devices as part of the Affordable Care Act. The medical device tax, which has long been decried by the industry as a measure that squashes innovation and kills jobs, has been on hold since 2014. The tax’s moratorium was extended

Trump tariffs place nearly $1 billion in duties on the medtech industry

The U.S. medical device industry is facing nearly $1 billion in tariffs from the Trump administration, about $4 billion less than what was originally expected, according to AdvaMed. Customs and Border Protection began collecting the additional duties on July 6. The Trump administration announced in April that it intended to impose tariffs on $50 billion

Here’s how FDA officials think you can legally promote off-label device, drug uses

The FDA has issued final guidance clarifying what it considers permissible off-label information for device makers and drug companies to convey to potential customers. A pair of guidance documents outlines how medtech and pharmaceutical companies can explain to payors and hospitals how their products can affect outcomes and potentially save money, beyond what the products’ indication with the

Trump tariffs leave medical device companies in the dark

U.S. medical device industry representatives, for now, appear to be taking a wait and see approach as President Donald Trump’s administration wrangles over trade policy and threatens tariffs against China. The status of China tariffs on medical devices is unknown at this time as the Trump administration continues to make changes to its trade policies

7 top stories that mattered for medtech in 2017

The medtech industry saw its transformation accelerate in 2017: Whether it’s the roster of largest companies, business models or the regulatory environment, times are a-changing. Competition is also heating up in areas including diabetes care and robotic surgery. Here are seven stories that mattered for the medical device industry this year. Next>>

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AdvaMed asks Trump to overturn medical device tax

AdvaMed CEO Scott Whitaker has penned a letter to President Donald Trump, urging the president to work with Congress to overturn the medical device tax. Whitaker in his letter today congratulated Trump on today’s passage of the Republican-backed tax plan, while noting that Congress has failed to suspend the 2.3% levy imposed on U.S. medical

Report: Value-based medtech payment models lack appropriate quality measures

A new report from Discern Health and supported by industry group AdvaMed claims that current value-based payment models lack quality measures which effectively assess medical technology value. In the report, investigators identified what they claimed to be “significant gaps” in eight clinical areas it studied that included medical devices indicated to treat those conditions. Report […]

Should the medical device industry pay user fees to CMS?

Achieving reimbursement from payers has become a major challenge for medical device companies. Could the solution lie in having them pay user fees to CMS – the way they do to FDA? That was the question floated by Nadim Yared, president of CVRx and the current chairman of AdvaMed, during this week’s Medtech Conference powered by

AdvaMed unveils new tools to assess medical device value

AdvaMed today launched a new value initiative that includes extensive tables of questions to help medical device companies formulate value-based arguments. The value framework also includes tools specifically designed for diagnostic technologies – and reports on understanding evidence and use cases. “Value” has become an important word in medtech in recent years as government and private

Superbugs: Diagnostic test makers think they have an answer

Becton Dickinson and other diagnostic test makers have launched a global push to promote more testing, in the hopes of identifying antibiotic-resistant superbugs before they become a serious problem. AdvaMedDx, a group that represents diagnostic test manufacturers, announced the initiative on Friday in collaboration with the Joint United Nations Program on HIV/AIDs at the World Economic Forum

The ACA is going to die: Why is medtech so quiet?

Some major medical device industry lobbying groups are staying mum for now about the expected repeal of the U.S. Affordable Care Act—even though an extensive overhaul of the national healthcare system would have a serious impact on medtech. With so much unpredictability around how the incoming Trump administration and the new Republican Congress will replace

Senate passes 21st Century Cures Act funding research and medicine

The Senate passed the 21st Century Cures Act on Dec. 7, in a 94 to 5 vote, leaving the $6.3 billion legislation for President Barack Obama to sign. “[We are] pleased that the president is intending to sign the bill,” said AdvaMed president and CEO Scott Whitaker. “Our view is it’s a great victory for