FDA Grants 510(k) Clearance for Traumagel to Control Bleeding

This is a developing story.

The FDA granted 510(k) clearance for Traumagel (Cresilon), a temporary external drug used to control moderate-to-severe bleeding. The hemostatic gel is plant-based and designed to stop and control bleeding within seconds after applied to wound at the point of care, according to the news release.

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“The ability to rapidly stop bleeding at the point of care and halt a life-threatening hemorrhage can be the difference between life and death for people with traumatic injuries,” Joe Landolina, CEO and co-founder of Cresilon, said in the news release. “The FDA clearance for Traumagel is a monumental milestone for Cresilon and brings us another step forward in our mission to save lives and transform the standard of care in emergency medicine. Our proprietary hemostatic gel technology is a game-changer and unlike any other hemostatic agent currently being used.”

Reference

Cresilon Receives FDA Clearance for TRAUMAGEL. News release. Cresilon. August 15, 2024. Accessed August 16, 2024. https://cresilon.com/2024/08/15/cresilon-receives-fda-clearance-for-traumagel/