A dataset of digital therapeutic device approvals to support regulatory decisions and industry research
Qichuan Fang·Jianbo Lei·Songping Li·Jingkai Zeng·Yongcheng Liu·Lifang Zhang·Lei Ye·Haitao Zhang·Y Q He·Lei Dong·Xiang Peng·Jiaming Liang
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, a