ArticleNPJ digital medicine2026
Landscape of regulatory clinical investigations status of traditional and digital medical devices in the Republic of Korea (2003-mid 2024).
Article in NPJ digital medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
This study analyzed 1556 clinical investigation plan approvals granted by the Ministry of Food and Drug Safety (MFDS) in the Republic of Korea by integrating regulatory databases and comparing the clinical investigation characteristics of traditional and digital medical devices (2003-mid 2024). Indicators included clinical investigation purpose, device classification, number of participating institutions, design characteristics, annual approval trends, major product categories, and time required from plan approval to marketing authorization. According to the Korean MFDS four-class medical device classification system (Classes 1-4), digital medical devices, predominantly concentrated in Class 2 and 3 software, exhibited a high proportion of Pivotal clinical investigations (68%); traditional medical devices, distributed among high-risk Class 3 and 4 devices, had a relatively higher proportion of exploratory investigations. The number of plan approvals for digital medical devices surpassed that of traditional devices for the first time in 2023; cognitive therapy and diagnostic assistance software constituted the major product categories. The mean time from approval to marketing authorization was significantly shorter for digital medical devices than for traditional medical devices.
Identifiers
What OpenQuestion holds
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.