ArticleIEEE open journal of engineering in medicine and biology2025
Advancements in Clinical Evaluation and Regulatory Frameworks for AI-Driven Software as a Medical Device (SaMD).
Article in IEEE open journal of engineering in medicine and biology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis 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
18 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Two-decade dialogue between artificial intelligence and osteoporosis: research trajectories and frontier projections under bibliometric and visual analysis.Frontiers in medicine · 2025Pooled it
- A guide for the deployment, validation, and accreditation of clinical digital pathology tools.Journal of pathology informatics · 2026Article
- Translational Barriers and AI-Driven Challenges of Microfluidics-Enabled Wearables and Implantable Systems in Personalized Medicine.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Review
- QHealthcare (Basel, Switzerland) · 2026Article
- Regulatory science for AI-basedJournal of pathology informatics · 2026Article
- Artificial intelligence in chronic kidney disease: Early detection, risk prediction, and personalized treatment strategies.World journal of nephrology · 2026Review
- AI in Drug Discovery: Clinical Failures, Regulatory Reality, and the Validation Crisis Behind the Hype.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Diagnostic Accuracy of Artificial Intelligence in Laryngeal Disorders: An Integrative Review.Journal of personalized medicine · 2026Review
- Artificial intelligence-assisted early screening of lung cancer and accurate diagnosis of pulmonary nodules: research progress and clinical prospects from radiomics to multi-omics integration: a narrative review.Journal of thoracic disease · 2026Review
- Geometric deep reinforcement learning with hierarchical variational autoencoders for de novo drug design and activity optimization.Journal of computer-aided molecular design · 2026Article
- Bone Grafts: Everything You Need to Know.Journal of periodontal research · 2026Review
- Virtual medicine: medical AI in human health and diseases.Military Medical Research · 2026Review
- Localized AI for stroke care in LMICs: a framework to overcome structural and diagnostic barriers.Frontiers in public health · 2026Review
- AI-augmented frameworks for enhancing Alzheimer's disease clinical trials: A memory clinic perspective.The journal of prevention of Alzheimer's disease · 2025Article
- Predictive Modeling for Clostridioides difficile Infection: Current State of the Science, Clinical Applications, and Future Directions.Infectious disease clinics of North America · 2025Review
- Current Trends and Future Opportunities of AI-Based Analysis in Mesenchymal Stem Cell Imaging: A Scoping Review.Journal of imaging · 2025Review
- Transformative Impact of Artificial Intelligence on Internal Medicine: Current Applications, Challenges, and Future Horizons for Urban Health.Juntendo medical journal · 2025Review
- Innovation trajectory of Software as a Medical Device: Evidence from the US FDA-approved products.Digital healthArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Owing to the rapid progress in artificial intelligence (AI) and the widespread use of generative learning, the problem of sparse data has been solved effectively in various research fields. The application of AI technologies has resulted in important transformations in healthcare, particularly in radiology. To ensure the high quality, safety, and effectiveness of AI and machine learning (ML) medical devices, the US Food and Drug Administration (FDA) has established regulatory guidelines to support the performance evaluation of medical devices. Furthermore, the FDA has proposed continuous surveillance requirements for AI/ML medical devices. This paper presents a summary of SaMD products that have passed the FDA 510 (k) AI/ML pathway, the challenges associated with the current AI/ML software-as-a-medical-device, and solutions for promoting the development of AI technologies in medicine. We hope to provide valuable information pertaining to medical-device design, development, and monitoring to ultimately achieve safer and more effective personalized medical services.
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.