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 ...

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

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

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

While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...

By establishing coding and separate payment for certain digital mental health devices, this group from CMS and the FDA hopes ...

The new director of the FDA’s device center contrasted a European rule with the lack of mandatory reporting requirements for ...