Q&A: How Kaiser Permanente tracks and weeds out risky medical devices

STAT June 24, 2024
Lizzy Lawrence

When a new medical device hits the market, there’s typically still some uncertainty about whether it works.

Device makers generally do not have to submit as much, or as rigorous, clinical data to the Food and Drug Administration as their biotech counterparts. Once FDA regulators decide a device is safe and effective, companies and researchers then attempt to track how the device performs in the real world.

But tracking devices is tricky. The FDA...

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