The agency plans in the coming months to issue a draft guidance with labeling recommendations for manufacturers and to hold a public advisory committee meeting to discuss whether the current pathway ...

The report is intended to predict what issues will be important in the coming year and make practical recommendations to hospitals to prevent them, said Robert Schluth, senior project officer of ...

Makers of surgical staplers and the implantable staples they’re loaded with will now need to jump through extra hoops before their products can be used to divide, seal and connect internal tissues for ...

The FDA is warning healthcare providers about the risk of serious injury, malfunction and death associated with surgical staplers and implantable surgical staples. Between January 2011 and March 2018, ...

Stapler maker Medtronic confirmed that its reporting exemption for surgical staples ended in mid-2017. FDA records show that its public reports of injuries and malfunctions soared, from about 1,000 in ...

The FDA has proposed to reclassify surgical staplers as higher-risk medical devices—therefore requiring premarket reviews, agency clearance and performance studies—following an increasing number of ...

SAN DIEGO, Jan. 28, 2019 /PRNewswire/ -- A recent study has found significant differences between surgical stapler technologies when it comes to the impact the devices have on the rate of air leaks, ...

The US Food and Drug Administration (FDA) sent a letter to health care providers Friday over a growing body of adverse events associated with surgical staplers and implantable staples. The agency’s ...

A surgical staple remover looks a bit like a handheld hole punch. Not the alligator-mouth contraption used for paper staples. I know this because my father recently had a radical prostatectomy to ...

CAMPBELL, Calif.--(BUSINESS WIRE)--ZipLine Medical, Inc. today announced publication of positive results from two significant clinical studies in two peer-reviewed journals demonstrating that use of ...