ReviewDiagnostics (Basel, Switzerland)2022
Trends in the Approval and Quality Management of Artificial Intelligence Medical Devices in the Republic of Korea.
Review in Diagnostics (Basel, Switzerland), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed.
- Landscape of regulatory clinical investigations status of traditional and digital medical devices in the Republic of Korea (2003-mid 2024).NPJ digital medicine · 2026Article
- [Analysis of the global registration status of clinical trials for artificial intelligence medical device].Sheng wu yi xue gong cheng xue za zhi = Journal of biomedical engineering = Shengwu yixue gongchengxue zazhi · 2025Article
- Artificial Intelligence-Based Software as a Medical Device (AI-SaMD): A Systematic Review.Healthcare (Basel, Switzerland) · 2025Review
- A decade of review in global regulation and research of artificial intelligence medical devices (2015-2025).Frontiers in medicine · 2025Review
- A dual analysis of bougie and stylet development trend and impact of Chinese regulations on medical devices innovation.American journal of translational research · 2024Review
- Pivotal trial of a deep-learning-based retinal biomarker (Reti-CVD) in the prediction of cardiovascular disease: data from CMERC-HI.Journal of the American Medical Informatics Association : JAMIA · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
Artificial intelligence (AI) is being implemented in many areas of medicine, such as patient-customized diagnosis. Growth in the artificial intelligence medical device (AIMD) field is expected in the coming years. Major countries are currently establishing systems and policies to gain a leading position in the medical artificial intelligence market. The Republic of Korea has initiated the Act on Nurturing the Medical Devices Industry and Supporting Innovative Medical Devices for the development of AIMDs and is implementing it preemptively. As a result, the country has achieved an effective strategy for coping with the COVID-19 pandemic, an increase in the number of AIMD approvals (85 approved as of September 2021), and the creation of a document pertaining to internationally harmonized guidelines on AIMD-related terms and definitions. However, in order to develop and activate more AIMD products, it is necessary to improve post-market management such as product change and quality control in addition to approval. Here, we review the current regulatory status of AIMD in the Republic of Korea and what needs to be improved for AIMD to be more developed and activated.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.