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A dataset of digital therapeutic device approvals to support regulatory decisions and industry research
Qichuan Fang1, Jun Liang2,3,4,5, Songping Li6
1School of Medical Technology and Information Engineering, Zhejiang Chinese Medical University, Hangzhou, Zhejiang Province, China.
Abstract:
Digital Therapeutics (DTx), as an evidence-based, software-driven medical intervention, are rapidly developing globally with corresponding regulatory frameworks being gradually established in multiple countries. However, there is currently a lack of unified and structured data resources to support in-depth cross-national comparative and industry analysis. To address this, this study aimed to construct a standardized dataset covering approved DTx devices from four countries: US, China, Germany, and Belgium. We identified devices through systematic searches of national public databases combined with a keyword strategy. Following rigorous multi-stage screening, standardized information extraction, and expert arbitration, 507 devices meeting international DTx criteria were ultimately included, encompassing 18 product characteristics. This dataset provides a comprehensive and reliable structured data foundation for regulatory decision-making, industry research, and cross-national policy analysis pertaining to DTx.
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