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House Committee Advances User Fees With Full Slate Of Device Amendments

 
• By Sue Darcey

House Energy and Commerce Committee members added a slate of industry-favored device amendments into the FDA Reauthorization Act before sending the bill to the chamber floor, including reforms targeting device accessories, medical imaging and post-market surveillance.

Capitol House

[Editors' note: Follow progress with legislation impacting the device and diagnostics industry with the Medtech Insight's US Congress Tracker.]

The House Energy and Commerce Committee approved the House FDA Reauthorization Act (FDARA), which includes the FDA-industry MDUFA...

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• By Brian Bossetta

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Industry Execs Talk Tariff Turbulence During MD&M East

 
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During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.

Debate On FDA User Fee Reauthorization Begins To Take Shape

 
• By Elizabeth Orr

A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.

Health Secretary Defends Spending Cuts During Senate Hearing On HHS Budget

 
• By Elizabeth Orr

Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.

More from Policy & Regulation

Tarver And Makary Emphasize Commitment To At-Home Healthcare Innovations In FDA Podcast

 
• By Elizabeth Orr

FDA officials Michelle Tarver and Marty Makary discussed advancements in home healthcare during a podcast. They highlighted the importance of continuous glucose monitors, emphasized home healthcare's benefits for chronic diseases, and mentioned the agency's efforts to streamline device development.

UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 
• By Natasha Barrow

The UK's regulatory agency is the first to join a new international network for oversight of AI in healthcare run by a non-profit organization, HealthAI, the global agency for responsible AI in health.

Volta Files For US FDA Approval Of Next-Gen Cardio Mapping Software After Winning Labeling Expansion

 
• By Marion Webb

Volta Medical received a labeling expansion for its AF-Xplorer mapping software to treat A-fib, which provides the clinical evidence needed to broaden US access. The company hopes for FDA clearance for its improved second-gen AF-Xplorer II software.