More than 1,300 AI-assisted medical devices have FDA approval ...

FDA's new medical device quality management rules align U.S. standards with global requirements and give inspectors new ...

"Ultimately, the Court cannot discount the high likelihood—as demonstrated by the FTC—that the Proposed Transaction, if ...

If you’re one of the many adults who hate needles, you may be in luck. Scientists have taken inspiration from squids’ high-pressure liquid jets and developed a needle-free device to inject drugs into ...

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device clearances. That includes the Jan. 17 green light of Myocene’s neuromuscular ...

Medical device makers are seeking an exemption from Donald Trump's tariffs they say will raise the price of their products and devastate the medical device and medical technology industry. In this ...

A new master research agreement with C3 Medical Device Consulting supports product development, technology innovation, and ...