ReviewCurrent cardiology reports2014
Approval of high-risk medical devices in the US: implications for clinical cardiology.
Review in Current cardiology reports, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 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
11 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Systematic review of the introduction, early phase study and evaluation of pyrocarbon proximal interphalangeal joint arthroplasty.PloS one · 2021Pooled it
- Medical Device Development Process, and Associated Risks and Legislative Aspects-Systematic Review.Frontiers in public health · 2020Pooled it
- Evaluation and Regulation of Artificial Intelligence Medical Devices for Clinical Decision Support.Annual review of biomedical data science · 2025Review
- Advancing Health Equity in the Cardiovascular Device Life Cycle.Circulation. Cardiovascular quality and outcomes · 2025Review
- Minimal Access in Pediatric Surgery: An Overview on Progress towards Dedicated Instrument Developments and Anesthesiologic Advances to Enhance Safe Completion of Procedures.Children (Basel, Switzerland) · 2024Article
- Fatigue Testing of Wearable Sensing Technologies: Issues and Opportunities.Materials (Basel, Switzerland) · 2021Review
- Development of New Endovascular Devices for Aneurysm Treatment.Journal of stroke · 2018Review
- The Role of the FDA and Regulatory Approval of New Devices for Diabetes Care.Current diabetes reports · 2017Review
- Overview of High-Risk Medical Device Innovation in Gastroenterology from 2000 to 2014: Enhancing the Pipeline.Digestive diseases and sciences · 2016Review
- How do Orthopaedic Devices Change After Their Initial FDA Premarket Approval?Clinical orthopaedics and related research · 2016Article
- Transvenous implantable cardioverter-defibrillator lead reliability: implications for postmarket surveillance.Journal of the American Heart Association · 2015Article
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
Abstract
Since 1976, the US Food and Drug Administration (FDA) has used the premarket approval (PMA) process to approve high-risk medical devices, including implantable cardioverter defibrillators (ICDs), coronary stents, and artificial heart valves. The PMA process is widely viewed as a rigorous evaluation of device safety and effectiveness, though recent recalls-most notably related to underperforming ICD leads-have raised concerns about whether physicians and patients should sometimes be more wary about devices approved via this pathway. The FDA must utilize a "least burdensome" approach to approve new medical devices, and many widely used device models have been approved as supplements to existing PMA-approved devices with limited clinical testing. A recent Supreme Court ruling has made it difficult for patients harmed by unsafe PMA-approved devices to seek damages in court. Cardiologists who utilize high-risk medical devices should be aware that FDA approval of new devices relies on variable levels of evidence and does not necessarily indicate improved effectiveness over existing models. Clinician and patient engagement in postmarket surveillance and comparative effectiveness research remains imperative.
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.