ArticleThe American journal of managed care2023
Time to publication of cost-effectiveness analyses for medical devices.
Article in The American journal of managed care, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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
1 citing paper in PubMed, 1 citations in OpenAlex.
- Two decades of growth and trends in the FDA authorization of digital medical devices.NPJ digital medicine · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author at 1 institution in 1 country.
Funding
Abstract
objectivesAcademic researchers and physicians have called for greater use of cost-effectiveness analyses in informing treatment and reimbursement decisions. This study examines the availability of cost-effectiveness analyses for medical devices, in terms of both the number of studies and when studies are published. STUDY
designAnalysis of the number of years between FDA approval/clearance and publication for cost-effectiveness analyses of medical devices in the United States published between 2002 and 2020 (n = 86).
methodsCost-effectiveness analyses of medical devices were identified using the Tufts University Cost-Effectiveness Analysis Registry. Studies in which the model and manufacturer of the medical device used in the intervention were identifiable were linked to FDA databases. Years between FDA approval/clearance and publication of cost-effectiveness analyses were calculated.
resultsA total of 218 cost-effectiveness analyses of medical devices in the United States published between 2002 and 2020 were identified. Of these studies, 86 (39.4%) were linked to FDA databases. Studies examining devices approved via premarket approval were published a mean of 6.0 years after the device received FDA approval (median, 4 years), whereas studies examining devices that were cleared via the 510(k) process were published a mean of 6.5 years after the device received FDA clearance (median, 5 years).
conclusionsThere are few studies describing the cost-effectiveness of medical devices. Most of these studies' findings are not published until several years after the studied devices received FDA approval/clearance, meaning that decision makers will likely not have evidence of cost-effectiveness when making initial decisions related to newly available medical devices.
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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.