Comparison of innovative medical devices between China and the United States.

Xu Song, Bo Yuan, Kai Zhang, Chunying Chen, Yuliang Zhao, Antonios G Mikos, Xingdong Zhang

Abstract read

In one paragraph

Article in Regenerative biomaterials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it

0cells of the map it votes in

0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Xu SongInstitute of Regulatory Science for Medical Devices, Sichuan University, Chengdu 610064, China.

Bo YuanSchool of Biomedical Engineering, Sichuan University, Chengdu 610064, China.

Kai ZhangInstitute of Regulatory Science for Medical Devices, Sichuan University, Chengdu 610064, China.

Chunying ChenCAS Key Laboratory for Biomedical Effects of Nanomaterials and Nanosafety and CAS Center for Excellence in Nanoscience, National Center for Nanoscience and Technology of China, Beijing 100190, China.ORCID https://orcid.org/0000-0002-6027-0315

Yuliang ZhaoCAS Key Laboratory for Biomedical Effects of Nanomaterials and Nanosafety and CAS Center for Excellence in Nanoscience, National Center for Nanoscience and Technology of China, Beijing 100190, China.

Antonios G MikosDepartments of Bioengineering, Chemical and Biomolecular Engineering, Rice University, Houston, TX 77251, USA.

Xingdong ZhangInstitute of Regulatory Science for Medical Devices, Sichuan University, Chengdu 610064, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

From October 1, 2014 to June 30, 2025, China and the United States (U.S.) have implemented varying degrees of reform in the review and approval systems for innovative medical devices (IMDs), establishing and developing special review pathways for such devices. These reforms aim to further encourage the development of IMDs and accelerate the provision of safe and effective medical solutions to patients with unmet clinical needs. In this perspective, we analyze data on IMDs granted IMD Designations and that received marketing authorizations, and examine their development trends.

Indexed as

breakthrough devices programcompound annual growth rateIMD designationsinnovative medical devicesmarketing authorizations

Identifiers

PMID41868305

DOI10.1093/rb/rbag008

PMCPMC13003204

What OpenQuestion holds

Textmetadata

LicenceCC BY

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.