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Device Week, 21 October 2021 – Post-Pandemic Perspectives; Good And Bad News For Medtronic

 
• By Reed Miller and Marion Webb

In this edition of Device Week, Medtech Insight’s Reed Miller discusses some important news from Medtronic and Marion Webb reviews the first of two feature articles on the impact of the pandemic on the medtech industry around the world.

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More from Diversity & Inclusion

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Disparities — Including Financial Shortcomings — Remain In Women’s Health, Execs Say

 
• By Brian Bossetta

FemTech leaders discussed some of the barriers that remain in unlocking the full potential of the women’s health market during SiS New York last week. They also offered solutions.

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 However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.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.

More from ESG

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.

ARPA-H Announces Grants To Advance Rural Care

 
• By Elizabeth Orr

The 12 initial awards, which total almost $100m, are part of an ongoing program to develop a high-tech mobile hospital that can reach patients with limited access to health care.