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In new guidance, FDA says AI tools to warn of sepsis should be regulated as devices
In new guidance, FDA says AI tools to warn of sepsis should be regulated as devices,In new guidance, the FDA specified that AI tools designed to warn providers about sepsis should come under regulatory review. Health software vendors have been selling such tools for years without obtaining clearance.

In new guidance, FDA says AI tools to warn of sepsis should be regulated as devices

The FDA has published a list of AI tools that should be regulated as medical devices, including those that alert about sepsis.