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FDA-authorized software as a medical device in mental health: a perspective on evidence, device lineage, and regulatory challenges
12 references·0 citing·49 second hop
FDA-authorized software as a medical device in mental health: a perspective on evidence, device lineage, and regulatory challenges (2025)FDA-authorized software as a medical devi…A digital therapeutic (CT-152) as adjunct to antidepressant medication: A phase 3 randomized controlled trial (the Mirai study) (2025)A digital therapeutic (CT-152…The three-year evolution of Germany’s Digital Therapeutics reimbursement program and its path forward (2024)The three-year evolution of G…Digital mental health: a potential opportunity to improve health equity in China (2024)Digital mental health: a pote…Current evidence on the efficacy of mental health smartphone apps for symptoms of depression and anxiety. A meta‐analysis of 176 randomized controlled trials (2024)Current evidence on the effic…FDA regulations and prescription digital therapeutics: Evolving with the technologies they regulate (2023)FDA regulations and prescript…Digital therapeutics from bench to bedside (2023)Digital therapeutics from ben…Smartphone apps for depression and anxiety: a systematic review and meta-analysis of techniques to increase engagement (2021)Smartphone apps for depressio…Comparing usage of a web and app stress management intervention: An observational study (2018)Comparing usage of a web and …Effectiveness of an online insomnia program (SHUTi) for prevention of depressive episodes (the GoodNight Study): a randomised controlled trial (2016)Effectiveness of an online in…Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up (2016)Effect of a Web-Based Cogniti…Respiratory and cognitive mediators of treatment change in panic disorder: Evidence for intervention specificity. (2010)Respiratory and cognitive med…Feedback of end-tidal pCO2 as a therapeutic approach for panic disorder (2007)Feedback of end-tidal pCO2 as…Intraclass correlations: Uses in assessing rater reliability. (1979)Anxiety sensitivity, anxiety frequency and the prediction of fearfulness (1986)Hyperventilation in panic disorder and asthma: Empirical evidence and clinical strategies (2010)Diagnostic and Statistical Manual of Mental Disorders (2013)Acceptance and Commitment Therapy versus Cognitive Behavior Therapy for Children With Anxiety: Outcomes of a Randomized Controlled Trial (2016)Positive affect treatment targets reward sensitivity: A randomized controlled trial. 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References

  • 2016Effectiveness of an online insomnia program (SHUTi) for prevention of depressive episodes (the GoodNight Study): a randomised controlled trial365 cited
  • 2016Effect of a Web-Based Cognitive Behavior Therapy for Insomnia Intervention With 1-Year Follow-up325 cited
  • 2024Current evidence on the efficacy of mental health smartphone apps for symptoms of depression and anxiety. A meta‐analysis of 176 randomized controlled trials213 cited
  • 2023Digital therapeutics from bench to bedside185 cited
  • 2021Smartphone apps for depression and anxiety: a systematic review and meta-analysis of techniques to increase engagement161 cited
  • 2007Feedback of end-tidal pCO2 as a therapeutic approach for panic disorder159 cited
  • 2010Respiratory and cognitive mediators of treatment change in panic disorder: Evidence for intervention specificity.141 cited
  • 2024The three-year evolution of Germany’s Digital Therapeutics reimbursement program and its path forward67 cited
  • 2018Comparing usage of a web and app stress management intervention: An observational study57 cited
  • 2023FDA regulations and prescription digital therapeutics: Evolving with the technologies they regulate51 cited
  • 2024Digital mental health: a potential opportunity to improve health equity in China19 cited
  • 2025A digital therapeutic (CT-152) as adjunct to antidepressant medication: A phase 3 randomized controlled trial (the Mirai study)14 cited

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