The medical device sector faces significant changes, as both Donald Trump and Robert F. Kennedy Jr. have identified the FDA ...

The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed ...

While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and ...

“We are very excited to receive FDA clearance ... best-in-class respiratory therapy devices used to deliver care to patients suffering from chronic respiratory conditions. Inogen partners with ...

kerala weekly Nature sub-journal: New drugs that may be approved by the FDA in 2020 Confirmed! Meituan starts selling high-risk Class II and Class III medical devices Inner Mongolia launches special ...

With the FDA's new requirements for premarket submission and ongoing monitoring by medical device manufacturers in place, ...

The spinal cord stimulation technology from Swiss company Onward, called ARC-E-X, helps paralyzed people regain some mobility ...

"Discover the dynamic intersection of pharmaceuticals and medical devices, where innovative drug-device combinations are revolutionizing healthcare. BCC Research Study Projects 9.1% CAGR ...

A recall of Impossible Foods products, a leading manufacturer of plant-based meat alternatives, has been classified as a Class II recall by the U.S. Food and Drug Administration (FDA). Newsweek ...

(RTTNews) - Gerresheimer AG (GRRMF.PK), a German systems and solutions provider for the pharma, biotech and cosmetic industries, announced Monday that the US Food and Drug Administration has ...

Dietmar Siemssen, CEO of Gerresheimer, said, "The regulatory authority's decision underlines the market readiness of our on-body drug delivery device. It also clearly demonstrates our expertise as ...

In a new analysis of AI and ML-enabled devices authorized by the Food and Drug Administration, Brewster and colleagues at Boston Children’s and Harvard Medical School found just that.