Medical devices

FDA responds to report of secret database

The FDA publicly swung into action Friday after Kaiser Health News illuminated a secret database that kept serious safety issues out of the public eye.

How it works: The FDA maintains a public database of injuries or other problems caused by medical devices. It's a valuable tool for researchers, and also for doctors, who want to assess devices' safety before using them in patients.

Scientists call for rules on evaluating predictive AI in medicine

Illustration of a doctor carrying a computer as a file
Illustration: Rebecca Zisser/Axios

Some scientists are calling on the Food and Drug Administration to establish standards for advanced algorithms that are developing at a "staggering" pace before they are put in medical devices to help predict patients' outcomes.

What's new: Advanced algorithms are starting to be deployed in some devices to help provide automated real-time predictions, but these offer a whole new level of possibilities and challenges from older predictive tools. Standards are needed to check for safety and effectiveness before they are implemented in a clinical setting, the scientists say in a policy forum in Science Thursday.

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