Medical software reSET-O®

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reSET-O, the first PDT to receive Breakthrough Designation and authorized by FDA in December 2018, is an 84-day Prescription Digital Therapeutic (PDT) for Opioid Use Disorder (OUD) intended to increase retention of patients in outpatient treatment by providing cognitive behavioral therapy (CBT), as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. An associated dashboard for clinicians and other health care providers can be used as part of treatment. The dashboard displays information about patients’ use of reSET-O, including lessons completed, patient-reported substance use, patient-reported cravings and triggers, patient-reported medication use, compliance rewards, and in-clinic data inputs such as urine drug screen results. reSET-O® Indications for Use: reSET-O prescription digital therapeutic is a 12-week (84 day) software application intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic. reSET-O® Important Safety information for Clinicians: Warnings/precautions: reSET-O is intended for patients whose primary language is English or Spanish with a reading level of 7th grade or above, and who have access to an Android/iOS tablet or smartphone.