August 2, 2025Frontiers in MedicineOpen Access

A decade of review in global regulation and research of artificial intelligence medical devices (2015–2025)

View Full Paper

Ask AI

Bookmark

Authors

Discussion

This review analyzes AI medical device regulations across regions, highlighting key policies and framework gaps.

Main finding: The regulatory landscape for artificial intelligence medical devices has evolved significantly since 2015.
Key evidence: Policies have been initiated by the U.S., EU, China, Japan, and South Korea to enhance safety and innovation.
Approach: Comprehensive analysis of regulatory policies and academic research related to AI medical devices.
Significance: Identifying gaps in standards helps improve oversight and supports innovation in AI medical devices.

Zhang et al. (2025) studied this question.

View Full Paper

Ask AI

Bookmark