For example, Brittany found that drugs being developed by Generate were modified versions of existing antibodies, and that ...

Artificial intelligence systems require consistent monitoring and staffing to put in place and to keep them working well.

For AI models that FDA determines are high risk ... same will hold true when the tool is an AI/ML based algorithm that may well need approval in its own right. It is also worth noting that ...

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 ...

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.

Research co-led by University of Toronto researchers and Insilico Medicine has demonstrated the potential of quantum computing and artificial intelligence to transform the drug discovery pipeline.

A Dayton-area medical technology firm has recently had its AI-driven image processing and analysis technology cleared by 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 ...