Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...

Following the Trump administration's DEI ban, the FDA's move to scrub webpages has ensnared many pages focused on ensuring ...

The US Food and Drug Administration (FDA) has granted 510(k) clearance for Imperative Care’s Zoom System, marking an ...

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

The FDA is urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the ...

The website changes raise concerns about “the interference of politics with the study and the practice” of science and ...

An update from Merit Medical Systems ( ($MMSI) ) is now available. On January 28, 2025, Merit Medical Systems held a conference call to discuss ...

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued ...

The FDA has granted medical manufacturer Beckman Coulter a Breakthrough Device Designation for its new plasma ratio, a blood ...

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

The U.S. Food and Drug Administration has pulled draft guidance from its website requiring companies to test medicines and ...

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