The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional ...

The U.S. Food and Drug Administration (FDA) said on Thursday it had identified three cybersecurity risks associated with certain patient monitors from Contec and Epsimed and urged healthcare ...

In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, ...

According to Grand View Research, the European and Middle Eastern drug screening markets are projected to grow significantly by 2030, with Europe expected to reach $3.6 billion and the Middle East and ...

NeuroPace, Inc. (NASDAQ:NPCE), a medical device company specializing in neurological disorders with a market capitalization of $439 million, has been making significant strides in the epilepsy ...

Robert F. Kennedy Jr., President Donald Trump's pick to lead the top U.S. health agency, told U.S. senators during his ...

When conducting a clinical investigation, meeting regulatory requirements is predicated on factors such as the quality of ...

Robert F. Kennedy Jr. vows to finalize regulations for greater diverse patient involvement in clinical trials during his ...

Lab-developed tests (LDTs) are laboratory tests where blood is drawn and placed in a test tube to help with identification, ...

FDA regulation of cosmetics and beauty products may change under the new administration. Here's what you need to know if that ...

Brenner, who worked in the FDA’s Center for Devices and Radiological Health, will take the helm of the agency until a new ...

The volume of U.S. FDA warning letters to device makers oscillated significantly in recent years, but the agency posted a handful of these letters to kick off the new year. Five letters were posted ...