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Background <p>The integration of artificial intelligence (AI) in radiology has accelerated globally, with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) approving numerous AI-based Software as a Medical Device (SaMD) products. However, the transparency and completeness of clinical evidence available to healthcare providers remain unclear.</p> Purpose <p>To systematically evaluate the availability and transparency of clinical evidence in package inserts of PMDA-approved AI-based radiology SaMD products, identifying gaps that may impact clinical implementation.</p> Materials and methods <p>We conducted a scoping review of all PMDA-approved SaMD products as of December 31, 2024. Products were included if they utilized AI technology and were classified for radiology applications. Data extraction focused on product characteristics, study designs, demographic information, and performance metrics.</p> Results <p>Of 151 approved SaMD products, 40 utilized AI technology, with 20 specifically designed for radiology applications. Critical gaps were identified in demographic reporting, with no products providing complete case demographic data. Performance metrics varied widely, with sensitivity ranging from 67.7% to 100% in standalone studies. Physician-assisted studies consistently demonstrated performance improvements but lacked stratified results by characteristics in all cases.</p> Conclusion <p>Current package insert requirements provide insufficient transparency for evidence-based clinical implementation of AI-based radiology SaMD. Enhanced regulatory frameworks and industry-led initiatives for comprehensive validation are essential for safe and effective AI deployment in Japanese healthcare.</p>

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Scoping review of regulatory transparency in AI-based radiology software: analysis of PMDA-approved SaMD products

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年1月14日

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  • Tomohiro Kikuchi,
  • Shannon L. Walston,
  • Hirotaka Takita,
  • Yasuhito Mitsuyama,
  • Rintaro Ito,
  • Masahiro Hashimoto,
  • Takeshi Nakaura,
  • Hiroaki Hyakutake,
  • Sho Kawabe,
  • Harushi Mori,
  • Daiju Ueda

摘要

Background

The integration of artificial intelligence (AI) in radiology has accelerated globally, with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) approving numerous AI-based Software as a Medical Device (SaMD) products. However, the transparency and completeness of clinical evidence available to healthcare providers remain unclear.

Purpose

To systematically evaluate the availability and transparency of clinical evidence in package inserts of PMDA-approved AI-based radiology SaMD products, identifying gaps that may impact clinical implementation.

Materials and methods

We conducted a scoping review of all PMDA-approved SaMD products as of December 31, 2024. Products were included if they utilized AI technology and were classified for radiology applications. Data extraction focused on product characteristics, study designs, demographic information, and performance metrics.

Results

Of 151 approved SaMD products, 40 utilized AI technology, with 20 specifically designed for radiology applications. Critical gaps were identified in demographic reporting, with no products providing complete case demographic data. Performance metrics varied widely, with sensitivity ranging from 67.7% to 100% in standalone studies. Physician-assisted studies consistently demonstrated performance improvements but lacked stratified results by characteristics in all cases.

Conclusion

Current package insert requirements provide insufficient transparency for evidence-based clinical implementation of AI-based radiology SaMD. Enhanced regulatory frameworks and industry-led initiatives for comprehensive validation are essential for safe and effective AI deployment in Japanese healthcare.