Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...

Almost 100,000 bottles of nasal spray were recalled for a "microbial failure" that led to multiple complaints from customers.

Johnson & Johnson said on Friday it resumed the limited market release of its Varipulse heart device in the United States ...

On January 7, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance, titled “Artificial ...

The U.S. Food and Drug Administration is urging all patients with smartphone-compatible diabetes devices to check the ...

Thomas Cooper’s parents hoped the oxygen therapy he was receiving at a facility in Troy, Michigan, would help his sleep apnea ...

Contec Medical Systems (“Contec”), a global medical device and healthcare solutions company headquartered in China, sells ...

District Judge John Bates wrote the removals harm “everyday Americans, and most acutely, underprivileged Americans, seeking ...

The FDA has issued a safety communication regarding the potential for missed alerts with diabetes devices due to software or hardware changes.

Scott Gottlieb supports a reversion to an earlier interpretation of the 21st Century Cures Act, which would exempt more types ...

Take a walk to your local smoke shop and look at the labels. The U.S. Food and Drug Administration only allows retailers to ...

AIM, a medical device company, agrees to a $1 million fine to settle a federal fraud probe over misbranded gear.