The smart thermometer performs a check-up on your body temperature, cardiac, and pulmonary health in less than a minute.

Withings announced that its multi-function medical device BeamO has received clearance from the FDA. BeamO contains sensors ...

The e-cigarettes include functions meant to appeal to youth, such as receiving text or call notifications, according to regulators. The FDA said part of the reason the products are likely to appeal to ...

AliveCor, the Mountain View, Calif.-based artificial intelligence and medtech company, has received FDA clearance for two more analyses on its AI-powered KardiaMobile electrocardiogram (ECG) device.

In a significant advancement in hearing and vision solutions, EssilorLuxottica has announced that its Nuance Audio Glasses have gained clearance from the Food and Drug Administration (FDA) for ...

Certain smartphone features such as battery saver, “focus mode” or “do not disturb” may change how alerts are delivered. The Food and Drug Administration (FDA) has issued a safety communication ...

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. Check out STAT’s exclusive ...

(RTTNews) - Ypsomed Holding AG (YPHDF) announced Monday that its digital connectivity add-on, SmartPilot, has received 510(k) clearance from the U.S. Food and Drug Administration or FDA. SmartPilot ...

The US Food and Drug Administration (FDA) is cautioning patients and caregivers about the potential for not receiving blood glucose level alerts from diabetes-related smartphone devices due to ...

A smart bandage could speed up wound healing by actively tracking and responding to the healing process. The proof-of-concept device, called a-Heal, was designed to fit inside a commercial colostomy ...