ReviewFrontiers in medical technology2025
Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European Union.
Review in Frontiers in medical technology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 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
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Methodologies for generating and evaluating clinical and performance evidence for high-risk and innovative medical devices andFrontiers in medical technology · 2026Pooled it
- Lean-Agile Product Development in FDA Relevant and Regulated Medical Device Contexts.Therapeutic innovation & regulatory science · 2026Review
- Detection and quantification of ezetimibe and its major glucuronide in patients with hepatic impairment via liquid chromatography-tandem mass spectrometry.Journal of pharmaceutical and biomedical analysis · 2026Article
- Artificial Intelligence Across the Drug Development Lifecycle.Medical sciences (Basel, Switzerland) · 2026Review
- Current Status and Future Perspectives of Wearable Technologies for Oral Health in Clinical Applications.Diagnostics (Basel, Switzerland) · 2026Review
- Review
- From innovation to implementation: expanding global access to mechanical circulatory support and heart transplantation.Frontiers in cardiovascular medicine · 2026Review
- Nanoscale Approaches to Oro-Dental Tissue Engineering: A Review of Strategies, Composites, and Translational Challenges.International journal of nanomedicine · 2026Review
- Mechanomedicine in digestive surgery: a theranostic framework integrating mechanical diagnostics and therapeutic modulation across the perioperative continuum.Theranostics · 2026Review
- Molecular insights into antimicrobial resistance in human bacterial pathogens: mechanisms, resistance genes, and translational diagnostic applications.Frontiers in microbiology · 2026Review
- The Challenges of Vascular Implants: Regulatory Strategies and Biological Responses.Small science · 2025Review
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
The landscape of medical device regulation is rapidly evolving, driven by innovations and the need to bring these technologies to patients more efficiently. This review provides a comprehensive analysis of the accelerated access pathways for medical devices in the United States (US) and the European Union (EU), focusing on the Breakthrough Devices Program (BDP) in the US and the evolving regulatory framework within the EU. Analysis of Food and Drug Administration (FDA) data reveals that from 2015 to 2024, only 12.3% of the 1,041 BDP-designated devices received marketing authorization, with mean decision times of 152, 262, and 230 days for 510(k),
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.