ArticleNature biotechnology2020
Early experience with the FDA's Breakthrough Devices program.
Article in Nature biotechnology, 2020. 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.
- Comparison of innovative medical devices between China and the United States.Regenerative biomaterials · 2026Article
- Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study.BMJ (Clinical research ed.) · 2025Article
- Physician-Patient Communication about Novel Drugs and High-Risk Medical Devices.Medical decision making : an international journal of the Society for Medical Decision Making · 2025Article
- Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European Union.Frontiers in medical technology · 2025Review
- Market of First Launch for High-Risk Therapeutic Medical Devices.JAMA network open · 2024Article
- Challenges and solutions to advancing health equity with medical devices.Nature biotechnology · 2023Article
- PreclinicalFrontiers in bioengineering and biotechnology · 2023Review
- Experts' Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care.Journal of general internal medicine · 2022Article
- A Policy Approach to Reducing Low-Value Device-Based Procedure Use.The Milbank quarterly · 2022Article
- Navigating the Regulatory Pathway for Medical Devices-a Conversation with the FDA, Clinicians, Researchers, and Industry Experts.Journal of cardiovascular translational research · 2022Review
- Changing FDA Approval Standards: Ethical Implications for Patient Consent.Journal of general internal medicine · 2021Article
- Device Therapy in Chronic Heart Failure: JACC State-of-the-Art Review.Journal of the American College of Cardiology · 2021Review
- Molecular cancer screening: in search of evidence.Nature medicine · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
PubMed holds no abstract for this paper.
Indexed as
Identifiers
32704171What 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.