Medical device, digital and diagnostic companies, wherever they may be based, have long been accustomed to market access challenges.
Medtech’s Role In The Carbon Neutral Challenge To Counter Climate Change – The UK View
Net zero environmental sustainability needs are bringing new ‘compliance’ requirements
“Sustainability executive” is a new job role for a new era. The UK’s largest healthtech industry association has appointed one, and many medtech companies in every geography might eventually do likewise, as the drive for nations to achieve carbon neutrality picks up pace. Medtech Insight spoke to the ABHI’s new incumbent Addie MacGregor and director of value and access Luella Trickett to gauge the size of the task before the medtech industry.
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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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Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.
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About 200 staff in the FDA’s Center for Devices and Radiological Health were among the 3,500 FDA employees let go in today’s staff reductions. The cuts, which one employee described as a “Manhattan Project” to the center, are already having a major effect on staff morale.
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.