Evidence map›Paper›PMID 40060145›Full record

ReviewBioactive materials2025

Advances in medical devices using nanomaterials and nanotechnology: Innovation and regulatory science.

Chubing Lin, Xin Huang, Yueguang Xue, Shasha Jiang, Chunying Chen, Ying Liu, Kuan Chen

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Bioactive materials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

22 citing papers in PubMed.

  1. Review
  2. Toxicity of nanostructures in drug delivery applications.Pharmaceutical science advances · 2026
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Chubing LinSchool of Biomedical Sciences and Engineering, South China University of Technology, Guangzhou, 511442, China.
Xin HuangSchool of Biomedical Sciences and Engineering, South China University of Technology, Guangzhou, 511442, China.
Yueguang XueSchool of Biomedical Sciences and Engineering, South China University of Technology, Guangzhou, 511442, China.
Shasha JiangThe 990th Hospital of the Jointservice Support Force of the PLA, Zhumadian, Henan province, 463000, China.
Chunying ChenCAS Key Laboratory for Biomedical Effects of Nanomaterials and Nanosafety & CAS Center for Excellence in Nanoscience, National Center for Nanoscience and Technology of China, Beijing, 100190, China.
Ying LiuCAS Key Laboratory for Biomedical Effects of Nanomaterials and Nanosafety & CAS Center for Excellence in Nanoscience, National Center for Nanoscience and Technology of China, Beijing, 100190, China.
Kuan ChenCenter for Medical Device Evaluation, National Medical Products Administration, Beijing, 100076, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Nanomaterials and nanotechnology are emerging as promising strategies for medical devices due to their advantageous properties, including the ability to effectively interact with biomolecules and tissues, as well as enhance therapeutic efficacy and biocompatibility. This has resulted in approved and candidate devices in fields, such as orthopedics, dentistry, wound care, and neurology. However, the overall progress in translating medical devices using nanomaterials has been relatively slow, highlighting the urgent need to advance regulatory science. Regulatory authorities and organizations, such as the National Medical Products Administration in China and the European Union, have issued essential guidance documents for these devices' safety and efficiency evaluation. These documents include special requirements and considerations for physicochemical characterization, biological evaluation, and other aspects. Although some evaluation paths have been defined, ongoing advancements in technologies and methods are expected to enhance safety evaluation practices, reduce burdens on the medical device industry, and accelerate the clinical translation of medical devices using nanomaterials. Herein, we review the current state of regulatory science related to medical devices using nanomaterials, suggest the feasibility of using

Indexed as

In vitro alternativeMedical deviceNanomaterialsRegulatory scienceSafety and efficiency evaluation

Identifiers

PMID40060145
PMCPMC11889687

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.