During a recent segment on Fox Business, Food and Drug Administration Commissioner Martin Makary, MD, clarified new guidance on AI, meant to provide companies with the flexibility to gather and provide data without the agency's approval. However, medical devices that provide "clinical-grade" data will still need to be cleared.

A veteran cardiologist is back on the job after reportedly being fired for his participation in a controversial CDC panel. His wife shared the update, saying they were "truly humbled" by everyone who came to his defense.

An impending policy change from UHC could cause providers to jump through additional hoops to receive payment for some imaging-related services. 

Based on feedback from the FDA, Aspire Biopharma plans on completing a multicenter clinical trial and then seeking regulatory approval for its new high-dose sublingual aspirin therapy. 

If you still think of large-language AI as a newish thing yet to catch on with healthcare consumers, think again.

The extensions are used to supply patients with fluids and drugs through an IV line. Despite being labeled as having them, the devices do not contain an air-eliminating vent. Because there is a serious risk of air embolism associated with the error, the FDA has given this recall its most serious designation.

This new-look RF ablation catheter moves through the use of computer-controlled magnets, providing electrophysiologists with improved maneuverability and precision.  

According to Gore, the newly approved device was built with conformability, strength and fracture resistance in mind.