Medical Innovation Exchange

patient access

Bringing Digital Health Products to the Global Market

Bringing Digital Health Products to the Global Market     In recent years, the growth and acceptance of digital health products has skyrocketed. Global regulation and market access for these devices, however, is as variable as the potential indications they address. We spoke with Megan Coder, Vice President for Product and Policy at the Digital Medicine …

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FDA Updates Breakthrough Devices Program Guidance

FDA Updates Breakthrough Devices Program Guidance     The FDA has issued an update to the final guidance: Breakthrough Devices Program. The updates are intended to clarify how the Breakthrough Devices Program applies to certain innovative medical devices that may address health inequities, as well as devices that may offer a non-addictive option to treat pain or …

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FDA Seeks Input on At-Home Use Medical Technologies

FDA Seeks Input on At-Home Use Medical Technologies     The FDA Center for Devices and Radiological Health (CDRH) is seeking input from the medical device industry, the public, patient advocacy organizations, healthcare providers and clinical researchers on at-home use medical devices. Expanding access to home use technologies is part of the CDRH’s 2022-2025 Strategic Priority …

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