ReviewFrontiers in medical technology2024
Navigating regulatory and policy challenges for AI enabled combination devices.
Review in Frontiers in medical technology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 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
23 citing papers in PubMed.
- Artificial intelligence in onco-anaesthesia: Current applications, challenges, and future directions.World journal of methodology · 2026Review
- Challenges and Recommendations in Regulating AI Medical Devices in the European Union: A Scoping Review.Healthcare (Basel, Switzerland) · 2026Review
- AI-bioinformatics synergy for precision medicine in brain diseases: integrating radiomics and multi-omics data.Briefings in bioinformatics · 2026Review
- Technology Review: The Hidden Influence of AI in Orthopaedic Surgery.Journal of the American Academy of Orthopaedic Surgeons. Global research & reviews · 2026Review
- Article
- Nanostructured electrode materials and flexible-substrate engineering for wearable multi-analyte biosensors in diabetes monitoring and personalized care: a comprehensive review.Journal of materials science. Materials in medicine · 2026Review
- Optimizing arthroplasty outcomes: the impact of artificial intelligence and robotic assistance.Annals of medicine and surgery (2012) · 2026Review
- When Cancer Clots: An Extensive Radiologic Analysis of Cancer-Associated Thromboembolism.Cancers · 2026Review
- The absence of full lifecycle risk management for AI-based medical devices in radiology.NPJ digital medicine · 2026Article
- Artificial Intelligence For 6P Medicine: Consolidating AI Needs of Predictive, Preventive, Personalized, Participatory, Precision, and Public Health Trajectories.Journal of medical systems · 2026Review
- The regulation of artificial intelligence in intensive care units: from narrow tools to generalist systems.NPJ digital medicine · 2026Review
- Data-driven medical devices and the EU MDR: mapping gaps in standards for regulatory compliance.npj health systems · 2026Review
- Rethinking Nature's Pharmacy: AI Era and Natural Product Drug Discovery.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Ethical oversight of AI-driven paediatric trials: a proactive, risk-sensitive interim review model.Frontiers in digital health · 2026Article
- Artificial Intelligence in Gastrointestinal Endoscopy: Current Advances, Clinical Integration, and Future Directions: A Narrative Review.Clinical and experimental gastroenterology · 2026Review
- A systematic review of explainable artificial intelligence methods for speech-based cognitive decline detection.NPJ digital medicine · 2025Article
- Predetermined Change Control Plans: Guiding Principles for Advancing Safe, Effective, and High-Quality AI-ML Technologies.JMIR AI · 2025Article
- Artificial intelligence in pediatric healthcare: current applications, potential, and implementation considerations.Clinical and experimental pediatrics · 2025Article
- Artificial Intelligence in Microsurgical Planning: A Five-Year Leap in Clinical Translation.Journal of clinical medicine · 2025Review
- Dualistic Dynamics in Neuropsychiatry: From Monoaminergic Modulators to Multiscale Biomarker Maps.Biomedicines · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In recent years, the Artificial Intelligence (AI) has enabled conventional Combination Devices (CDs) to innovate in healthcare merging with technology sectors. However, the challenges like reliance on predicate devices in US Food and Drug Administration (FDA's 510(k) pathway, especially for perpetually updating AI are stressed. Though the European Union (EU's new Medical Device Regulations address software and AI, fitting adaptive algorithms into conformity assessments remains difficult. The urgent need for frameworks cognizant of AI risks like model degradation and data biases is emphasized. Insights from recalled devices and case studies elucidate challenges in regulatory navigation for manufacturers. Adaptive policy frameworks balancing patient safeguards and rapid innovation are proposed. Recommendations target regulators and policy makers, advocating global standards to enable safe, effective and equitable AI adoption. This article aims to examine AI-enabled combination device regulation, inspecting US and EU strategies as well as obstacles for manufacturers and regulators.
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.