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Cognita Imaging wins FDA contract to test LLMs in evaluating radiology AI

Published

18 September 2026

Topic

opportunities

◆ Sectors

Medtech

◆ Geography

United States

◆ Source

Read at medtechdive.com →

◆ Verified

Fusion42 · 19 September 2026 · Fusion42 review

Cognita Imaging has secured a contract with the FDA to test large language models (LLMs) for evaluating radiology AI, supporting the FDA's efforts to regulate generative AI-enabled medical devices.

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

◆ ◆ The Wire takeaway

You must prepare your AI systems for new FDA evaluation protocols using language models; early alignment with this testing could unlock smoother approvals.

◆ Coverage

1 source · 18 Sep 2026

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MedtechFDAradiology-aiLLM-testingregulatory-compliancegenerative-ai