Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...

In fact, FDA has begun to closely scrutinize their use — including by issuing Warning Letters — as further described herein. Medical Device Definition & FDA Enforcement Discretion In general ...

Now that we're a month out from CES, these are the trends that have stuck with me. Yes, AI is on the list, of course, but so ...

Nightingale Health Plc Press release 7 February 2025 at 2:15 p.m. (EET)Nightingale Health Plc ("Nightingale Health"), a pioneer in disease risk detection and preventative health announces its regulato ...

Prof. Zeev Rotstein, former CEO of Sheba and Hadassah hospitals; Ruti Keidar, Head of Healthcare at Microsoft EMEA; and ...

The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.

Smart watches, rings, and a growing array of patches are adding more functionality and being used across a growing set of ...

Jacek Olczak; Chief Executive Officer, Director; Philip Morris International Inc Emmanuel Babeau; Chief Financial Officer; Philip Morris International Inc Matthew Smith; Analyst; Stifel, Nicolaus & Co ...

the ACLA sued FDA in federal court on May 29, 2024, arguing that the regulations "inappropriately" seek to regulate LDTs. "The medical device framework is inappropriate and ill-suited for ...

Advanced Aesthetic Technologies, Inc. ("AAT") announced today that their partner in China has obtained approval to market their unique dermal filler Algeness® VL agarose facial injection filler, a 2.5 ...

Arena International’s Outsourcing in Clinical Trials West Coast 2025 will discuss patient centricity, diversity, and ...