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

An update from Merit Medical Systems ( ($MMSI) ) is now available. On January 28, 2025, Merit Medical Systems held a conference call to discuss ...

Medical device makers including Abbott, Johnson & Johnson and Medtronic want an exemption from Trump tariffs that could hit ...

The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.

Medical announced an approval from the U.S. Food and Drug Administration, FDA, of an Investigational Device Exemption IDE, ...

Medical devices are ... year of the Food and Drug Administration’s (FDA) new guidance on security and privacy play out, putting pressure on manufacturers in both the premarket and postmarket.

Acrivon Therapeutics said the Food and Drug Administration has granted Breakthrough Device designation for its ACR-368 OncoSignature assay, an immunofluorescence assay for the identification of ...

The approval Journey Medical received from FDA for Emrosi makes DERM an exciting stock. Click here to read more.

A new study suggests clinical utility of the first FDA-approved genetic test to help gauge an individual’s risk for opioid ...

Blue Goat Cyber sponsors MedTech World Dubai 2025 to help medical device manufacturers secure connected healthcare technologies an ...