Abstract

Four years ago, the federal Food and Drug Administration (FDA) awarded eight companies “Innovation Challenge” grants to spur the development of medical devices that would prevent and treat opioid use disorder (OUD) (see https://onlinelibrary.wiley.com/doi/10.1002/adaw.32191). This month, the FDA cleared the Masimo Opioid Halo — the first winner of the challenge — for over‐the‐counter availability for use on adults and children aged 15 and older, and a prescription version for use from a health care provider.

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