Affiliation:
1. Department of Pharmaceutical Sciences, College of Pharmacy University of Illinois Chicago Chicago Illinois USA
2. John A. Paulson School of Engineering and Applied Sciences Harvard University Cambridge Massachusetts USA
3. Wyss Institute for Biologically Inspired Engineering at Harvard University Boston Massachusetts USA
Abstract
AbstractDigital therapeutics are emerging as a new form of therapeutic interventions. Unlike conventional therapeutics, digital therapeutics deliver interventions directly to patients using an evidence‐based, clinically evaluated software to treat, manage, or prevent diseases. Digital therapeutics manifest in diverse forms such as web‐based applications, mobile applications on smart devices, virtual reality, and video games. As its own product category for FDA approval, digital therapeutics can function as stand‐alone treatments or in combination with conventional therapeutics to improve adherence and/or efficacy. Here, we review the clinical landscape of digital therapeutics. We summarize FDA‐approved products and their clinical use, overview >300 ongoing clinical trials, and discuss challenges for their clinical translation and strategies to overcome the same.
Subject
Pharmaceutical Science,Biomedical Engineering,Biotechnology
Reference105 articles.
1. Understanding DTx. Accessed January 13 2023.https://dtxalliance.org/understanding-dtx/
2. Diabetes Digital App Technology: Benefits, Challenges, and Recommendations. A Consensus Report by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) Diabetes Technology Working Group
3. The diagnostic and triage accuracy of digital and online symptom checker tools: a systematic review
4. FDA.FDA launches the digital health center of excellence. 2020. FDA.gov.
5. FDA.Digital Health Software Precertification (Pre‐Cert) Pilot Program.2022Accessed September 13 2022https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-pilot-program
Cited by
23 articles.
订阅此论文施引文献
订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献