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  FDA Updates Breakthrough Devices Guidance Focused on Health Equity

  The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity, as well as considerations in designating eligible devices that may benefit populations impacted by disparities in health…

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  FDA Updates Breakthrough Devices Program Guidance

  The updated guidance clarifies how the program applies to medical devices that may address health inequities, as well as those that may increase access to care or provide a non-addictive treatment option to treat pain or addiction. It also clarifies…

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  Swiss National Council Votes To Accept FDA Approved Medical Devices

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