The U.S. Food and Drug Administration (FDA) is warning health care providers and people with diabetes of risks associated with use of devices for diabetes management unauthorized for sale in the U.S., whether used alone or along with other devices. These unauthorized diabetes management devices have not been reviewed by the FDA to ensure they provide a reasonable assurance of safety and effectiveness for their intended use. Use of unauthorized devices could result in inaccurate glucose level readings or unsafe insulin dosing, which can lead to injury requiring medical intervention or death.
SUBJECTIVE: Abstract from the article titled, "Wearable Are Totally Failing The People Who Need Them Most" posted on Wired Magazine: "As the Internet of Things becomes an actual thing, more steps are being counted, more sleep patterns are being logged, more activities are being appified. What isn’t appearing in the data is much common sense or ambition. Instead,...