Edwards Lifesciences sent a formal request to CMS in February after its Evoque TTVR device gained FDA approval. The agency is now accepting public comments for 30 days.

Trokamed sent a letter to customers warning them to never use its Mini PCNL Sheaths for suction and irrigation, due to a risk of kidney rupture. 

The self-expanding device is now available in more than 20 countries and received CE mark approval back in 2020. However, it has not yet been approved by the U.S. Food and Drug Administration for use in the United States.

The tirzepatide shortage that first began in 2022 has been resolved. Drug companies distributing compounded versions of the popular drug now have two to three more months to distribute their remaining supply.

CCTA is being utilized more and more for the diagnosis and management of suspected coronary artery disease. An international group of specialists shared their perspective on this ongoing trend.

For artificial intelligence to truly transform care, the healthcare industry must address certain challenges. Jens Eldrup-Jorgensen, MD, a veteran vascular surgeon and member of the Society for Vascular Surgery, explains in a guest editorial. 

Boston Scientific is recalling the catheters associated with its POLARx Cryoablation System due to a heightened risk of esophageal injury. The FDA has ruled that this a Class I recall.

Merck sent Hansoh Pharma, a Chinese biopharmaceutical company, an upfront payment of $112 million to license a new investigational GLP-1 receptor agonist. There could be many more payments to come if certain milestones are met.