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<p>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.</p>

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A dataset of digital therapeutic device approvals to support regulatory decisions and industry research

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年4月23日

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  • Qichuan Fang,
  • Jun Liang,
  • Songping Li,
  • Jingkai Zeng,
  • Yongcheng Liu,
  • Lifang Zhang,
  • Lei Ye,
  • Huaqing Zhang,
  • Yunfan He,
  • Lei Dong,
  • Peng Xiang,
  • Jianbo Lei

摘要

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.