What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.

Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...

While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are having greater impacts on the smallest patients—including in neonatal ...

The draft guidance provides recommendations on the content of marketing submissions (e.g., 510(k) premarket notifications, premarket approval applications) for devices that include artificial ...