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Harmonizing EPA And Industry Needs: EtO Emissions

 
• By Hannah Daniel

The EPA and medtech industry want the same things: Cleaner air and a steady supply of medical devices. So how do they reconcile their differences?

wooden factory with magnifying glass on blue background
• Source: Shutterstock

As the comment period for the US Environmental Protection Agency’s proposed rules on new ethylene oxide (EtO) emissions standards closes, AdvaMed CEO Scott Whitaker wants to enter discussions with the agency as "partners, not adversaries."

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FDA Scrubs ‘Gender’ From Final Guidance On Sex-Specific Data But Encourages More Women In Clinical Trials

 
• By Brian Bossetta

The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.

Drop Email Pronouns And Return To Work, Administration Orders FDA Staffers

 
• By Brian Bossetta

Chaos continues at the FDA’s device center as reinstated staffers begin daily commutes to comply with the administration’s return to office policy. Staffers can no longer publicly share their pronouns per Trump’s “Defending Women” executive order.

Brooklyn Medtech Works To Bring Hospital-Level Care To Remote Areas

 
• By Elizabeth Orr

10XBeta is helping to develop a modular mobile health care platform as part of a federal initiative to improve the quality of care in rural areas. Company CEO Marcel Botha told Medtech Insight that the product fits the company’s goals of bringing treatment to the people who need it most.

AI Bias Page, Health Equity Discussion Paper Back On FDA Site

 
• By Elizabeth Orr and Sue Sutter

Two US FDA device center websites have been restored under a restraining order. The pages now carry a disclaimer alleging they include "extremely inaccurate" content about gender; however, neither site includes any substantive discussion of trans issues.

More from Medtech Insight

Execs On The Move: 24-28 March 2025

 
• By Medtech Insight Team

An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.

Roar Of Eargo-hearX Merger Echoes Through US OTC Hearing Aid Market

 
• By Malcolm Spicer

The firms recently announced they will operate as combined company LXE Hearing marketing Eargo’s namesake line and hearX’s Lexie brands. Eargo majority owner Patient Square Capital added $100m to its investment.

Birmingham City University Develops New Defense Mechanism Against Cyberattacks On AI Systems

 
• By Natasha Barrow

AI systems used in healthcare are vulnerable to adversarial cyberattacks, which are a growing concern, said Atif Azad, a professor of AI at Birmingham City University. Azad’s research group has developed a method that trains AI to become more resilient to cyber threats through the use of random image adjustments.