Epitomee Medical has received approval from the US Food and Drug Administration (FDA) for the Epitomee Capsule, an ingestible ...

For the first-time ever, the Food and Drug Administration has authorized an over-the-counter hearing aid software. The FDA has approved Hearing Aid Feature, a device that will work with versions ...

The tech giant last week received FDA approval for its newest AirPods to perform clinical grade hearing tests and act as hearing aids. Apple (AAPL) has received approval from the Food and Drug ...

Epitomee Medical Ltd. (TASE: EPIT), announced that the United States Food and Drug Administration (FDA) has officially ...

The U.S. Food and Drug Administration ... the FDA approved it. A 510(k) Premarket Notification in a medical device database updated on Monday reveals the FDA approved an "Over-the-counter device ...

According to the FDA's approval notice, the Apple Watch sleep apnea function is not a diagnostic tool, but rather an over-the-counter device designed to assess watch-wearers' risk of sleep apnea.

The availability of an FDA-approved OTC device could also reduce the risk that individuals may unwittingly buy a falsified or unapproved device online. Prescription CGMs can often be seen offered ...

Stock of Applied Therapeutics, Inc. surges as FDA skips AdCom for AT-007 in galactosemia. Read more on recent developments ...

The U.S. Food and Drug Administration Monday published approval for sleep ... the on-board accelerometer. The FDA classes the feature as an “over-the-counter device to assess risk of sleep ...

"Weight loss medications are not one size fits all and patients should always discuss options with a trusted medical professional," one expert told Newsweek.

Ozempic (semaglutide) is a prescription-only injectable medication approved by the Food and Drug Administration (FDA) to treat type 2 diabetes. When used alongside a well-balanced diet and ...