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Foundation Model

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Four Questions Reveal FDA’s Expected Approach to Regulating Generative AI in Medical Devices

Four Questions Reveal FDA’s Expected Approach to Regulating Generative AI in Medical Devices

The U.S. Food and Drug Administration is developing guidance for using generative artificial intelligence in medical devices, focusing on competency-based evaluation, foundation models, and post-market monitoring. Fundamental questions remain open about the limits of oversight and companies’ responsibility for declining model performance over time.

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Mistral AI Raises $3.5 Billion at a Valuation Exceeding $24 Billion

Mistral AI Raises $3.5 Billion at a Valuation Exceeding $24 Billion

French company Mistral AI raised $3.5 billion in a Series D round led by Samsung Electronics, lifting its valuation to more than $24 billion and preserving its position as Europe’s most valuable company developing foundational artificial intelligence models.

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FDA Updates List of AI-Enabled Medical Devices and Prepares to Track Foundation Models

FDA Updates List of AI-Enabled Medical Devices and Prepares to Track Foundation Models

The U.S. Food and Drug Administration has updated its list of AI-enabled medical devices authorized for marketing in the United States, emphasizing that the list is not exhaustive and does not represent a complete database of all devices. The agency is exploring future mechanisms to identify devices that incorporate foundation models, including large language models and multimodal systems.