As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, ...

The AP reported that the Trump administration's latest federal cuts have a significant effect on medical device regulation at ...

Tech adoption might slow down if the FDA layoffs shift responsibility for medical device and AI safety to hospitals.

"Any place that gets cut, it's going to have an impact, because there's not any spare personnel at FDA,” said former agency ...

The FDA and its Center for Devices and Radiological Health (CDRH) were among several health-focused agencies caught in ...

The Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) met on Tuesday to optimize the facilitated review pathway (FRP) to expedite access to essential ...

Nasal vaccine devices have the potential to offer more convenient and more effective protection against a variety of viruses.

Health Canada recently published draft regulations to address therapeutic product shortages in Canada. The Regulations Amending Certain ...

Gottlieb, who led the FDA from 2017 to 2019, wrote that “recent changes to policies related to the regulation of AI have ...

FDA Layoffs Shake Up Neuralink Trial Review Team. In a surprising move, the U.S. Food and Drug Administration (FDA) has laid off around 20 employees from its Office of Neurologica ...

OnePlus is hoping the OnePlus Watch 3 could get FDA approval for its new sleep apnea detection feature, bringing it one step ...