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

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

The U.S. Food and Drug Administration has approved Supernus Pharmaceuticals' drug-device combination to treat ...

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.

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 ACR-368-tailored OncoSignature assay is being used to predict patients most likely to respond to ACR-368 in Acrivon’s ongoing, ...

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.

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 ...