On top of being a day for brands to post “pranks” on social media, April 1 was also the deadline to apply for the CMMI ACCESS ...

Add Yahoo as a preferred source to see more of our stories on Google. Whoop's wearable devices measure metrics including sleep, heart rate and blood pressure. The company received a warning letter ...

LeBron James, other athletes have joined financing for wearable devices company.

Dec 3 (Reuters) - Niche fitness-tracking firms such as WHOOP are coming under increased regulatory scrutiny as technological advances blur the lines between wearable and medical devices, exposing them ...

Under new Food and Drug Administration (FDA) guidance on "low risk" wearable technology and software, AI-powered health tools are rapidly expanding, leading to major implications for cost, access, and ...

As new consumer hardware and software capabilities have bumped up against medicine over the last few years, consumers and manufacturers alike have struggled with identifying the line between “wellness ...

South Korean Woori IO, a developer of noninvasive continuous glucose monitors, believes new FDA rules regarding wearables will accelerate the company’s commercialization process. Woori, which was ...

Wearable devices and digital apps that are available to consumers are emerging as potential tools in neurological care. These include smart watches and fitness trackers to monitor heart rate, physical ...

Apple boosts transparency by requiring regulated medical device disclosure for health apps in the EEA, UK, and US.

The Food and Drug Administration on Tuesday released two final guidance documents that would loosen regulations for certain types of wellness and software products. FDA Commissioner Marty Makary ...