Medical device, digital and diagnostic companies, wherever they may be based, have long been accustomed to market access challenges.
Now, they are facing a new test of their abilities, where the stakes are higher, not confined to the health...
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
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“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.
Keep up with the top medtech business and regulatory news.
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The US FDA has published a discussion paper as part of an effort to ensure all patients have timely access to safe and effective medical devices. The agency says the paper fits into a larger strategy of promoting health equity and is seeking public comment on the initiative.
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The E in ESG: SUDs, reuse, disposables, refurbishing, reprocessed devices? Multiple panelists at the 2024 MedTech Forum addressed the role medtech manufacturers should have in the climate change challenge.
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A fiscal 2025 report from the US House Appropriations Committee instructs the FDA to halt implementation of its overhaul of LDT regulation. Members also showed concern about overseas device manufacturing and the availability of over-the-counter diagnostics.
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The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks makes minor changes to its phthalates benefit-risk guidelines based on stakeholder feedback. The guidelines could be increasingly relevant given their applicability to other carcinogenic, mutagenic or reprotoxic (CMR) and endocrine-disrupting (ED) substances, lists that are bound to go on growing as the EU implements its Chemicals Strategy for Sustainability under the Green Deal.
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AdvaMed president Scott Whitaker said the group is focused on the need for tariff stability in conversations with the Trump administration. The organization remains optimistic about other policy areas. New chairman and ResMed CEO Mick Farrell laid out his five priorities.
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Class III devices and panel-track supplements approved by US FDA’s Center for Devices and Radiological Health. Data derived from FDA.gov. Updated weekly.
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AdvaMed president Scott Whitaker said the group is focused on the need for tariff stability in conversations with the Trump administration. The organization remains optimistic about other policy areas. New chairman and ResMed CEO Mick Farrell laid out his five priorities.
