On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...

A federal judge will soon decide whether to dismiss a lawsuit against UnitedHealth Group alleging that the company and its ...

The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.

The FDA has approved nearly a thousand artificially ... look at the performance of a model of an algorithm, AI-enabled or not, when it’s deployed.” Perhaps the most common AI product in ...

During the company's fourth-quarter earnings call Thursday, Arduini said the company has no plans to slow down. During the ...

Separately, wary of data drift and other post-approval changes in an AI model ... and incorporate algorithms exhibiting a degree of opacity.” To increase transparency, FDA’s guidance calls ...