Regulatory submission for the device was supported by a multinational, prospective, controlled clinical study.

The US Food and Drug Administration (FDA) recently warned a distributor and medical device maker for marketing continuous positive airway pressure (CPAP) machines and related software for treating ...

Add Yahoo as a preferred source to see more of our stories on Google. FDA commissioner Marty Makary made the announcement during the 2026 CES trade show The US Food and Drug Administration (FDA) is ...

Claria Medical announced today that it received FDA de novo authorization for its Claria system for minimally invasive ...

The FDA’s draft MDUFA VI agreement proposes new, faster pre-submission track, changes to de novo communication and more.

The US Food and Drug Administration (FDA) recently issued two warning letters to companies for marketing medical devices ...

FDA has expanded its early alert pilot program to cover all medical devices, according to a September 29 notice. In November 2024, the FDA’s Center for Devices and Radiological Health launched the ...

The U.S. Food and Drug Administration (FDA) issued a warning letter to BMC Medical, citing regulatory violations involving the company’s G3X APAP devices, which are imported into the United States by ...

Bioness’s PoNS system is designed to improve gait impairment in stroke patients by stimulating the trigeminal and facial ...

Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer ...

The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...