Sajid Javid, the UK’s secretary of state for health and social care announced the first-of-its kind review into the biases affecting the function of medical devices.
UK Government Points At Oximeters For Contributing To Disparity In COVID-19 Outcomes
Sajid Javid, the UK’s secretary of state for health and social care, wants to collaborate with the US Department of Health and Human Services to investigate biases in monitoring and diagnostic devices.
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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 However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.
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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.
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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.
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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.
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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.
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A six-year project aiming to establish a “less fragmented and more democratic” approach to clinical studies has commenced in the EU.
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Several pages on the US FDA website related to diversity and inclusion are down, which aligns with Trump’s recent executive order on diversity, equity, and inclusion. However, the Department of Health says there's been a “short pause” in communications to allow the incoming team to get in place.