While there have been no reported deaths, certain lots of Olympus single-use guide sheath kits are to be quarantined immediately. 

The recall comes after approximately 3% of patients treated with the device during the early stages of its U.S. rollout experienced a stroke or transient ischemic attack following surgery. The expected stroke rate is closer to 1%, the FDA explained.

The ACC, AHA, HFSA, HRS and SCAI all worked together to try and make the new board a reality. Though their proposal has been denied, the groups say they are not done fighting. 

The rapid rise of CCTA represents one of cardiology’s biggest ongoing trends, but most primary care providers are still not embracing a CT-first strategy.

The historic heart procedure was part of a series of operations that saved the lives of three young girls. “The whole situation is extraordinary, whether you look at it from the standpoint of a scientific breakthrough or the average person’s point of view,” one parent said. 

Though effective, Lu-177 radioligland therapy is not without side effects, some of which can be severe.

The Outsourcing Facilities Association, a Texas-based trade group, is alleging that supply issues still remain for Ozempic and Wegovy. The group believes the FDA has ignored those issues.

The acquisition helps Teleflex expand its interventional and vascular portfolios. Biotronik, meanwhile, is shifting its focus toward implantable devices and digital healthcare.