ArticleNPJ digital medicine2026
Two decades of growth and trends in the FDA authorization of digital medical devices.
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
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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
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The regulatory environment for digital medical devices has rapidly changed in recent years as policymakers have worked to keep up with the evolving landscape of biomedical technologies. Despite the need for new regulatory efforts, existing data assets in the US are not capable of systematically tracking whether FDA-authorized medical devices have digital components, limiting regulators' ability to incorporate software-specific considerations into post-market surveillance activities and limiting other stakeholders' ability to understand the extent of digitization of different medical specialty areas and product categories. We pioneer a new application of text analysis, using records from tens of thousands of regulatory documents for newly authorized medical devices, to describe the digital transformation of the US medical device industry over the past two decades. We show that the number of medical devices with digital components has grown substantially over time, with meaningful heterogeneity across clinical specialties.
Identifiers
What Socratic 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 Socratic graph.