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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Pear Picks Up Prescription Opioid App Clearance
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.
Deal Watch: Gilead’s Immunology Collaboration With Verily Continues Pivot Away From Virology
Gilead’s tie-up with Google’s Verily will explore the immunological underpinnings of rheumatoid arthritis, lupus and GI disorders. Janssen acquires BeneVir and its oncolytic virus expertise, while United Therapeutics buys out SteadyMed.
Medtech Tools To Help Address Opioid Crisis Face Reimbursement Challenges
A wide variety of devices that could either serve as pain-relief substitutes for opioids, help manage opioid addictions or tackle distribution issues with the overly prescribed medications are facing reimbursement challenges at the US Centers for Medicare and Medicaid Services.