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Medical Devices / Submissions and Approvals

FDA OK’s Mobile App for Assisting Opioid Use Disorder Treatments

Dec. 12, 2018
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The FDA granted 510(k) clearance for Pear Therapeutics’ reSET-O, an app designed to help patients with opioid use disorder stick with their recovery programs.

The app is meant to be used with buprenorphine and contingency management, a behavior modification therapy.

After receiving a doctor’s prescription for the app, it can be downloaded onto a mobile device for use with active participation in an opioid use disorder treatment program. It serves as a training, monitoring and reminder tool for patients and healthcare providers.

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