The FDA’s implementation of AI tools marks the next step in the agency’s digital transformation efforts. Lets take a closer ...

Due to increasing complexity of modern technology, FDA should consider updating its 510(k) process. Devices are not drugs. That is to say, the requirements for safe and effective drugs and devices ...

The Institute of Medicine (IOM) has released a report highly critical of the FDA's 510(k) medical device clearance process and called on the FDA to develop "a new framework that used both premarket ...

AUSTIN, Texas — On the way to adopting low-k dielectrics, the world's largest foundry has run smack into a problem that is proving difficult to solve. Although Taiwan Semiconductor Manufacturing Co.