ArticleBiomedicines2025
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting.
Article in Biomedicines, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 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
13 citing papers in PubMed.
- When the algorithm passes the test but fails the patient.PLOS digital health · 2026Article
- Intelligent Real-Time Healthcare and Biomedical Monitoring Systems: A Narrative Review of AI, IoT, and Emerging Technologies.Bioengineering (Basel, Switzerland) · 2026Review
- Perspectives on the Limits and Clinical Alignment of Medical AI from Population Statistics to Individual Care.Bioengineering (Basel, Switzerland) · 2026Article
- Putting the I in AML: Artificial Intelligence and Machine Learning in Acute Myeloid Leukemia.Cells · 2026Review
- Clinical Specialty Expansion of AI-Enabled and Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration From 1995 to 2025: Longitudinal Content Analysis.Journal of medical Internet research · 2026Article
- Article
- Algorithmic bias in surgical risk prediction models and its impact on patient safety: a review.Patient safety in surgery · 2026Review
- Review
- Use and Public Reporting of Predetermined Change Control Plans for AI-Enabled Medical Devices.JAMA health forum · 2026Article
- Immunologically Adaptive Endovascular Devices: Integrating Thrombo-Inflammation, Biomaterials Design, and Artificial Intelligence for Precision Cardiovascular Intervention.International journal of molecular sciences · 2026Review
- Implementing generative artificial intelligence in precision oncology: safety, governance, and significance.Journal of hematology & oncology · 2026Review
- Governing medical AI under the EU AI Act: an integrated compliance-by-design framework.Frontiers in digital health · 2026Article
- Artificial intelligence standardizes CT-based body composition analysis in breast cacer to address methodological heterogeneity.Frontiers in oncology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
PubMed holds no abstract for this paper.
Indexed as
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.