Thus, the Signia surgical stapling system was born. The Signia was designed with built-in smart technology to detect the ...

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The agency plans in the coming months to issue a draft guidance with labeling recommendations for manufacturers and to hold a public advisory committee meeting to discuss whether the current pathway ...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 FDA has granted reporting exemptions over the years for both surgical staplers and staples, agency records show. Stapler maker Medtronic confirmed that its reporting exemption for surgical staples ...

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 ...

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 ...

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 ...

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 ...

Today, the U.S. Food and Drug Administration issued a Letter to Health Care Providers to alert them that the agency is aware of an increasing number of medical device reports associated with the use ...

Staple line reinforcement during laparoscopic sleeve gastrectomy is associated with increased leakage from the stomach compared with not using this technique, according to a study published in the ...