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Cognita Imaging wins FDA contract to test LLMs in evaluating radiology AI
◆ Sectors
Medtech
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United States
◆ Source
◆ 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