Happify Health, a New York-based mental health tech company, has launched “Ensemble”, the first transdiagnostic prescription digital therapeutic (PDTx) in the US to treat Major Depressive Disorder (MDD) and Generalized Anxiety Disorder (GAD). The product will be available to patients for free with a prescription or through an investigational study.
Ensemble’s software delivers cognitive behavioral therapy and mindfulness exercises The app provides patients with the tools to change negative thinking patterns and track their progress. The tool can also be integrated into physicians’ electronic health records.
The PDTx was not cleared by the US Food & Drug Administration but Happify was able to launch the product due to the relaxed guidance issued in April 2020. The company plans to use real-world data to apply for FDA clearance within the next 18 to 24 months.
Founded in 2012, Happify Health offers a self-care app and AI-powered chatbot that helps users navigate mental health challenges. The company also develops evidence-based digital therapeutic and care delivery tools for healthcare providers, health plans, individuals, and pharmaceutical manufacturers.
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