Compremium AG today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to ...

On July 31, 2025, the U.S. Food and Drug Administration (FDA) issued its final guidance document “Medical Device User Fee Small Business Qualification and Determination,” which supersedes its previous ...

The FDA formally kicked off its quinquennial process to reauthorize the federal user fee legislation that helps fund its medical device reviews by hosting discussions with the medtech industry and ...

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 ...

The Food and Drug Administration (FDA) published new guidance for AI-enabled medical devices on January 7, 2025. These are nonbinding and not for implementation. The public comment window for these ...

The Food and Drug Administration issued a much-anticipated update on Tuesday detailing how it plans to regulate changes to artificial intelligence-enabled medical devices after the agency has ...

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

Earlier this month, FDA released a new draft guidance document outlining recommendations for lifecycle management and marketing submissions of AI-enabled device software functions. The guidance ...

FDA has issued a new warning to consumers regarding certain uses of radiofrequency microneedling devices. FDA claims that it has seen several serious complications caused by consumers using ...

The Federal Drug Administration’s current cybersecurity requirements are not appropriate for addressing and avoiding medical ...