The agency plans in the coming months to issue a draft guidance with labeling recommendations for manufacturers and to hold a public advisory committee meeting to discuss whether the current pathway ...

Surgical staplers and staples are used both externally and internally. Removable skin staples are medical devices, used externally to close wounds under high tension, including wounds on the scalp or ...

An independent health safety group identified misuse of surgical staplers as a top health technology concern. The ECRI Institute, a nonprofit that maintains a database of hospital-reported adverse ...

Intuitive Surgical ISRG recently announced that it has received FDA clearance for the first stapler specifically designed for use with single-port (SP) robotic surgical systems. The SureForm 45 ...

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, ...

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 ...

The FDA has acknowledged an increasing number of safety reports linked to surgical staplers and plans to re-evaluate whether the commonly used devices should receive more federal oversight and undergo ...

The US Food and Drug Administration (FDA) is alerting clinicians about an increasing number of medical device reports (MDRs) associated with the use of surgical staplers for internal use and ...

STOUGHTON, Mass., May 19, 2025 /PRNewswire/ -- Massachusetts based Trax Surgical, LLC, an orthopedic product development and distribution company principally serving the needs of the orthopedic ...

Staple line reinforcement helps mitigate bleeding during bariatric and other procedures Staple line bleeding can cause significant complications for patients New format of Peri-Strips Dry is made from ...