ArticleJAMA health forum2025
Early Recalls and Clinical Validation Gaps in Artificial Intelligence-Enabled Medical Devices.
Article in JAMA health forum, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses that pooled it.
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
10 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Pooled it
- Assessment of the Diagnostic Performance and Clinical Impact of AI in Hepatic Steatosis: Systematic Review and Meta-Analysis.Journal of medical Internet research · 2026Pooled it
- Knowledge-Practice Performance Gap in Clinical Large Language Models: Systematic Review of 39 Benchmarks.Journal of medical Internet research · 2025Pooled it
- When the algorithm passes the test but fails the patient.PLOS digital health · 2026Article
- 1,357 AI medical devices cleared, 3 actually tested on patient outcomes.PLOS digital health · 2026Review
- PROACTIVE-AI: An Intelligent Dashboard for Assessing and Predicting of FDA-approved AI Software Performance in Real-World Clinical Scenarios.Research square · 2026Article
- Artificial stupidity or logimorphism? How misuse of language warps our thinking about 'artificial intelligence'.European heart journal. Digital health · 2026Article
- Clinical Evidence and FDA Recalls of Artificial Intelligence-Enabled Medical Devices.JAMA network open · 2026Article
- The absence of full lifecycle risk management for AI-based medical devices in radiology.NPJ digital medicine · 2026Article
- The fairness paradox in public regulatory summaries of FDA-authorized artificial intelligence-enabled medical devices.Frontiers in 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
PubMed holds no abstract for this paper.
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.