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Wire · regulatory

ADLM Urges CLIA Oversight of AI Tools in Clinical Laboratories

16 September 2026 · By · Wire by Fusion42

Published

16 September 2026

Topic

regulatory

◆ Sectors

Medtech

◆ Geography

United States

◆ Source

Read at clpmag.com →

◆ Verified

Fusion42 · 16 September 2026 · Fusion42 review

The Association for Diagnostics & Laboratory Medicine (ADLM) recommends that AI tools in clinical laboratories remain regulated under the US Clinical Laboratory Improvement Amendments (CLIA) framework, with laboratories responsible for validating and monitoring these tools to ensure test quality and patient safety.

This Wire brief sits within Fusion42's coverage of Medtech.

◆ ◆ The Wire takeaway

You must prepare to ensure your AI tools comply with CLIA oversight as laboratories will remain accountable for AI validation and monitoring. This keeps AI as part of the clinical testing process, so integrating robust quality controls now will secure compliance and market trust.

◆ Coverage

1 source · 16 Sep 2026

◆ Related on Wire

◆ Topics

Medtechai-oversightclinical-labsregulatorycliapatient-safety