Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is getting better, and use is not mandatory.

But three of those FDA employees told CNN that Elsa just makes up nonexistent studies, something commonly referred to in AI ...

The Food and Drug Administration's new AI tool, Elsa, is reportedly generating false studies, raising concerns about the ...

Current and former members of the FDA told CNN about issues with the Elsa generative AI tool unveiled by the federal agency last month. Three employees said that in practice, Elsa has hallucinated ...

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission ...

In recent years, Artificial Intelligence (AI) has made significant strides across various sectors, providing innovative solutions and enhancing efficiency. However, ...

But according to three current FDA employees “ELSA” is creating studies that don’t exist. They say that makes it hard to ...

Earlier this year, the FDA unveiled Elsa, an artificial intelligence tool that's expected to speed up the process for ...

Artificial intelligence tools in health care should be safe and effective. They should be fair to people of different races, genders, and geographies. And they should be monitored to ensure they ...

The use of artificial intelligence in medicine is accelerating rapidly, and large companies — from Google, to Amazon, to Microsoft — are dedicating huge sums to developing novel products that ...

Current law does not really define the FDA’s powers to regulate devices that depend on advances in artificial intelligence and machine learning, as applied to health care.