The Apple Watch provides a pair of health-tracking features that measure your heart rate and heart rhythm, each officially cleared by the United States Food and Drug Administration (FDA). However, blood oxygen monitoring that's available on the new Apple Watch Series 6 model doesn't need a clearance from the FDA, and here's why.
The Kardiaband EKG reader from AliveCor is the very first Apple Watch accessory to receive an FDA approval as a medical device. The accessory is able to detect atrial fibrillation and abnormal heartbeats.
The United States Food and Drug Administration announced today a new pilot program designed to help Apple and other technology companies develop new digital health accessories faster while maintaining some government oversight.
Thanks to a recent Freedom of Information Act filing, we now know that Apple is still interested in developing a pair of FDA-regulated devices dedicated to cardiac monitoring.
This was revealed in a recent email exchange between officials at Apple and the United States Food and Drug Administration (FDA), which was obtained Tuesday by Mobihealthnews.
Economic Daily News reported on Apple's alleged interest in the creation of two health-tracking hardware products back in August. According to that report, the devices—one of which described as a “killer” gadget—should release some time in 2017.
The United States Food and Drug Administration (FDA) is taking a light, “almost hands-off” approach, to wearable devices like the Apple Watch that encompass non-essential health-related functions, Bloomberg reported Monday.
Apple's Watch and other new products from other vendors can be developed without aggressive regulation as the agency doesn't want to stand in the way of any technology that can motivate a person to stay healthy.
The Food and Drug Administration ruled on Friday that it will be taking a hands-off approach when it comes to the regulation of health apps and software.
VentureBeat reports apps that simply convey and track data will be left alone and won't need specific approval by the FDA like apps that provide specific medical advice. This is big news for the Apple Watch when it ships in April.
We know Apple's upcoming Watch, due in March, will double as a fitness and a health tracking device, but could it be classed as a regulated medical device?
According to the preliminary guidelines published Tuesday on the United States Food and Drug Administration's website, any wearable device which wants to be considered a medical device must prove that it can treat specific diseases or conditions, as first noted by AppleInsider.
If not, any such device should be considered a general wellness gadget, not a regulated medical device.
We know that Apple was in a health-oriented talk with the U.S. Food and Drug Administration last December, but the specifics of that discussion were not revealed until this morning. Three months after filing a Freedom of Information Act request, Apple Toolbox has received an official response from the FDA about what it talked about with the world's most valuable tech corporation. Read ahead for highlights from the conversation…