The Galien Foundation recently announced nominees for most innovative medical devices for its 13th Annual Prix Galien USA Awards. The foundation awards the Prix Galien Award annually to examples of outstanding biomedical and technology product achievements that are designed to improve human condition. Nominees need to be FDA approved for market within the last five […]
Sandoz, Pear launch digital therapy for opioid use disorder
Novartis (NYSE:NVS) division Sandoz and Pear Therapeutics this week kicked off the U.S. commercial launch of the first FDA-cleared prescription digital therapy for people with opioid use disorder. The companies partnered to commercialize a 12-week cognitive behavioral therapy intended to be used in tandem with outpatient treatment. The therapy includes transmucosal buprenorphine and contingency management designed to reinforce positive behaviors, […]
Pear Therapeutics wins FDA nod for digital opioid addiction treatment app
Pear Therapeutics has received FDA 510(k) clearance for its reSET-O medical application that helps treat patients who have an opioid use disorder. The reSET-O app is a prescription cognitive behavioral therapy that is designed to be used with outpatient treatment and under the care of a healthcare professional. It is also designed to be used […]
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