Digital Therapeutics (DTx), as an innovative digital interventional method, is internationally regarded as a prescription "digital drug" with significant potential in chronic disease management and mental health. China's "Healthy China 2030" strategy supports healthcare digital transformation. However, there's a lack of systematic analysis on DTx products approved by China's National Medical Products Administration (NMPA). Also, there are challenges such as an imperfect regulatory framework and insufficient clinical evidence.
Conduct a systematic analysis of the characteristics of DTx products approved by the NMPA, systematically review approval trends, indication distribution, and industrial landscape, to provide evidence for regulatory policy optimization and industrial development.
Research data were primarily sourced from eight medical device databases of the NMPA. Using independent keyword searches, a total of 20 107 candidate devices were generated. After screening, 235 devices meeting the definition of DTx were identified. Seventeen product features were extracted, and statistical analysis was performed using SPSS 25.0 software.
As of December 2024, NMPA had approved 235 devices that meet the definition of DTx. The number of approvals had increased yearly since 2018, with a significant increasing in 2022. Most were domestically produced (n=227, 96.60%) and approved (n=219, 93.19%) by local medical products administrations. The majority were Class Ⅱ medical devices (n=224, 95.32%), with core functions mostly focused on disease treatment (n=207, 88.09%), widely used for nervous system diseases (n=108, 45.96%). Nearly all require prescriptions (n=227, 96.60%) and often used guided behavioral intervention techniques (n=135, 57.45%). Digital technologies mainly involved online medical services (n=145, 61.70%) and primarily targeted the adult population (n=163, 69.36%). Manufacturers were mostly in economically developed regions.
China's DTx industry is growing due to policy support. But there are obstacles like an incomplete regulatory framework, insufficient evidence generation, and a lack of business models. It's suggested to enhance regulatory policies, emphasize real world evidence, and raise academic attention to support wider DTx adoption.
Stroke is one of the main causes of death and disability among residents in China, which imposes a heavy burden on patients and society. Digital therapy, as an emerging treatment method, has shown great potential in the management of the entire stroke course. This article reviewed the research progress of digital therapy in stroke screening, prevention, acute phase management, rehabilitation, and long-term follow-up. It analyzed the advantages and challenges of clinical application of digital therapy and looked forward to future development directions. Current research showed that digital therapy could significantly improve the coverage and accuracy of stroke risk screening, provided personalized and high-intensity intervention plans in rehabilitation training, and improved long-term patient management outcomes through remote monitoring. However, digital therapy still faces many challenges in standardized evaluation systems, evidence-based medicine, elderly patient adaptability, data security, and medical insurance policies. In the future, it is necessary to strengthen high-quality clinical research, improve standardized evaluation systems, promote interdisciplinary collaboration, and formulate reasonable medical insurance policies to promote the standardized application and development of digital therapies in stroke prevention and treatment.
Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder, and its chronic nature and high correlation with many chronic diseases make its diagnosis and long-term management a great challenge. The traditional treatment model has obvious shortcomings in terms of efficiency, resource allocation, and patient compliance. In primary care, general practice emphasizes a person-centered, comprehensive management model, playing a crucial role in the early screening, diagnosis, and long-term follow-up of OSA. In recent years, the rapid development of artificial intelligence (AI) technology and its application in OSA screening, diagnosis, personalized treatment plan development and long-term follow-up have significantly improved the efficiency and accuracy of OSA diagnosis and treatment, especially through wearable devices, telemedicine and multimodal data analysis to realize the intelligent transformation of OSA management, which provides new solutions to OSA diagnosis and treatment. This review systematically described the epidemiological characteristics of OSA, the attributes of chronic diseases, and the limitations of the existing diagnosis and treatment modes, and explored the practical applications and potentials of the deep integration of general practice and AI technology in OSA management, as well as its current challenges and future prospects. It was emphasized that the future management of OSA needed to promote multidisciplinary collaboration and strengthen the deep integration of general practice and AI technology, to achieve precise and personalized high-quality management of OSA and related chronic diseases.
