Opioid Use Disorder App Marks A Path For 510(k) 'Breakthrough' Devices
Pear Therapeutics announced US Expedited Access Pathway designation earlier this month for its 510(k)-route reSET-O Prescription Digital Therapeutic for OUD, perhaps providing some insight into the types of products seeking a "substantial equivalence" claim that might, nonetheless, be considered breakthroughs.
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Novartis subsidiary Sandoz will lead the US launch of Pear Therapeutics' reSET-O prescription-grade mobile app for opioid use disorder in the coming days following US FDA go-ahead.
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