More than 200 people with diabetes have been injured when their insulin pumps shut down unexpectedly due to a problem with a connected mobile app, the US Food and Drug Administration said Wednesday.
More than 200 people with diabetes have been injured when their insulin pumps shut down unexpectedly due to a problem with a connected mobile app, the US Food and Drug Administration said Wednesday.
Cool.
Unfortunately firmware-related problems especially is something regulatory bodies haven’t kept up with. They’ll test the device, sure. But not necessarily every line of code that might ever interact with it.
Overall they are operating under outdated levels of complexity while medical device manufacturers are running ahead with wireless functionality, mobile apps, over the air updates, etc.