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Want to Have It All? Work In Government, Attorney Says

An interview with FDA lawyer Anne Walsh

 
• By Hannah Daniel

Anne Walsh speaks to Medtech Insight about her practical advice for women in the legal field and why she volunteers to provide networking opportunities for female lawyers.

Anne Walsh
• Source: Hyman, Phelps & McNamara, P.C.

Friday, March 8 is International Women’s Day. To celebrate the day and Women’s History Month, Medtech Insight spoke with female leaders in medtech, regulatory and health care delivery about their experiences as women, women-specific industry challenges including research and innovation needs, and how women in leadership roles today are inspiring and empowering rising generations.

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US Medtech Tariffs: How Will EU Navigate Unchartered Territory?

 
• By Amanda Maxwell

US President Trump has imposed sweeping tariffs that encompass medtech. These are expected to drive up costs, disrupt supply chains and hinder innovation, likely driving the EU to seek new trade partnerships to mitigate the impact.

Democrats Condemn Trump’s HHS Layoffs During House Hearing On OTC Drug User Fees

 
• By Malcolm Spicer

Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.

LDT Saga Comes To A Grinding Halt As Judge Sides With Labs, Vacates FDA’s Final Rule

 
• By Brian Bossetta

A federal judge in Texas delivered what is most likely a fatal blow to the US FDA’s final rule, which would have regulated lab-developed tests as medical devices.

US Federal Trade Commission Challenges Surmodics-Biocoat Merger Over Antitrust Concerns

 
• By Elizabeth Orr

A planned merger between medical device coating manufacturers Surmodics and Biocoat is facing an antitrust lawsuit from the US Federal Trade Commission. The FTC believes the move would create an illegal monopoly.

More from Policy & Regulation

Notified Bodies Warn Of Hurdles In The Way Of Their AI Designations

 
• By Amanda Maxwell

Will challenges in the way of designations of notified bodies that assess AI-enabled medical devices create delays and bottlenecks and slow EU medtech innovation?

Guidance Feedback Highlights Outstanding Questions In AI Development

 
• By Elizabeth Orr

Many of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples. Stakeholders recommended the inclusion of case studies, metrics, and clearer guidelines to enhance the utility of the guidance, which is seen as a vital step for AI integration in healthcare.

Keeping Germany’s Medtech Industry Apprised, Advised and Incentivized in Turbulent Times

 
• By Ashley Yeo

A change of government, hospital reform and a drive towards healthcare digitization are keeping German medtech manufacturers on their toes. Making the MDR more user-friendly and winning support for a medtech strategy are arguably bigger priorities. US export tariffs have also pushed their way onto the agenda. BVMed chief executive Marc-Pierre Möll puts it all into context.