ReviewNPJ digital medicine2026
Current challenges and the way forwards for regulatory databases of artificial intelligence as a medical device.
Review in NPJ digital medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed.
- The landscape of artificial intelligence-enabled medical devices in the EU and the US intended for intensive care units.NPJ digital medicine · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Effective regulatory oversight is a key step in ensuring that artificial intelligence as a medical device (AIaMD) is safe in real-world clinical settings. In this Perspective, we provide insights from our experience working with international regulatory databases, informed by our recent research and the expertise of the multidisciplinary authorship team. We highlight four key challenges, discuss attempts to circumvent these limitations, and highlight emerging initiatives. Nevertheless, the underlying issue of the quality and availability of input data from regulatory databases remains. We discuss considerations for improving accessibility and transparency, outline key aspects for a next-generation regulatory data ecosystem for AIaMDs, and call on global stakeholders to come together and align efforts to develop a clear roadmap to accelerate safe innovation and improve outcomes for patients worldwide.
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.