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.
Fang et al. (Thu,) studied this question.