Medical Devices

Above my pay grade, but I've heard enough stories to suggest the regulation is not what it needs to be.

More than 200 people with diabetes were 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.

Version 2.7 of the t:connect Apple iOS app – used with the t:slim X2 insulin pump with Control-IQ – has been recalled due to a software issue that causes the app to crash and relaunch. This cycle drains the pump battery, causing it to shut down sooner than expected and suspend insulin delivery.

No idea who is to blame here, but having dealt with my inlaws and hearing aids, whenever Apple does an iOS update, there's a good chance the hearing aid app breaks in some way, and that is not a system you can put life sustaining devices on.