SynthesisFrontiers in medical technology2026
Methodologies for generating and evaluating clinical and performance evidence for high-risk and innovative medical devices and
Synthesis in Frontiers in medical technology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Introduction: High-risk and innovative medical devices (MDs) and Methods: A comprehensive and systematic search of major bibliographic databases and grey literature sources was conducted (January 2025, updated November 2025). Studies were selected through dual independent screening using predefined inclusion criteria. Data were extracted using a structured approach and supported by AI-assisted thematic analysis. Findings were synthesized narratively to map methodological approaches to evidence generation and evaluation. Results: A total of 15,679 records were identified, with 14,259 remaining after duplicate removal and 859 full texts assessed for eligibility. Of these, 90 studies met the inclusion criteria. In addition, records identified through other methods were screened, with 75 progressing to full-text assessment; of these, 8 were included Conclusions: An integrated lifecycle approach is needed for robust evaluation of high-risk and innovative MDs and IVDs. Strengthening methodological standards, improving the quality of real-world data, and enhancing regulatory harmonization are essential. Systematic Review Registration: Open Science Framework (OSF), doi: 10.17605/OSF.IO/XNBSP.
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What Socratic 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 Socratic graph.