ArticleFrontiers in neuroscience2022
First Food and Drug Administration Cleared Thin-Film Electrode for Intracranial Stimulation, Recording, and Monitoring of Brain Activity-Part 1: Biocompatibility Testing.
Article in Frontiers in neuroscience, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
What it found
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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.
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Who cites it
11 citing papers in PubMed, 18 citations in OpenAlex.
- Scaling beyond the vagus nerve: historical and contemporary progress on electrode-based small-diameter peripheral nerve interfaces.Bioelectronic medicine · 2026Review
- A Translational Platform for Polyimide Neural Interfaces: Polyimide Synthesis and in Vivo Evaluation in Epileptic Mice.IEEE access : practical innovations, open solutions · 2026Article
- Can bionic eyes restore vision? Breakthroughs, challenges, and future frontiers in ophthalmology - A comprehensive review.Journal of biological engineering · 2025Article
- Microinvasive Probes for Monitoring Electrical and Chemical Neural Activity in Nonhuman Primates.ACS chemical neuroscience · 2025Article
- The Next Frontier in Brain Monitoring: A Comprehensive Look at In-Ear EEG Electrodes and Their Applications.Sensors (Basel, Switzerland) · 2025Review
- Challenges and opportunities of acquiring cortical recordings for chronic adaptive deep brain stimulation.Nature biomedical engineering · 2025Review
- Failure behavior of polymer microelectrode arrays encapsulated with conventional ALD and 3D-ALI barriers.Frontiers in bioengineering and biotechnology · 2025Article
- Biomaterials for neuroengineering: applications and challenges.Regenerative biomaterials · 2025Review
- Polyimide as a biomedical material: advantages and applications.Nanoscale advances · 2024Review
- The application of impantable sensors in the musculoskeletal system: a review.Frontiers in bioengineering and biotechnology · 2024Review
- Electrochemical Testing of a New Polyimide Thin Film Electrode for Stimulation, Recording, and Monitoring of Brain Activity.Micromachines · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Subdural strip and grid invasive electroencephalography electrodes are routinely used for surgical evaluation of patients with drug-resistant epilepsy (DRE). Although these electrodes have been in the United States market for decades (first FDA clearance 1985), their fabrication, materials, and properties have hardly changed. Existing commercially available electrodes are made of silicone, are thick (>0.5 mm), and do not optimally conform to brain convolutions. New thin-film polyimide electrodes (0.08 mm) have been manufactured to address these issues. While different thin-film electrodes are available for research use, to date, only one electrode is cleared by Food and Drug Administration (FDA) for use in clinical practice. This study describes the biocompatibility tests that led to this clearance. Biocompatibility was tested using standard methods according to International Organization for Standardization (ISO) 10993. Electrodes and appropriate control materials were bent, folded, and placed in the appropriate extraction vehicles, or implanted. The extracts were used for
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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.