FDA clears 2 treatments for emergency bleeding

The US Food and Drug Administration has green-lighted two new products designed to stop severe bleeding. Cresilon’s Traumagel received 510(k) clearance, meaning the agency approved it as a new medical device. The product, a plant-based gel that comes in a syringe, is designed to be inserted at the surface of a wound to stop “all types of bleeds,” according to Brooklyn, New York–based Cresilon. Meanwhile, Octapharma’s octaplasLG Powder, a lyophilized form of blood plasma, received an emergency use authorization that specifically allows military personnel to administer it when plasma is unavailable or impractical. The powder is a freeze-dried version of Octapharma’s pooled blood plasma, octaplas, which the FDA approved in 2013.

Authors

Publication Details

Journal
C&EN Global Enterprise
Published
2024-08-26
DOI
https://doi.org/10.1021/cen-10226-buscon16
Primary Topic
Diverse Legal and Medical Studies
Type
article
Field-Weighted Citation Impact
0.00
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article

FDA clears 2 treatments for emergency bleeding

Rowan Walrath
C&EN Global Enterprise
Diverse Legal and Medical Studies
article

FDA clears 2 treatments for emergency bleeding

Rowan Walrath
article en

Abstract

The US Food and Drug Administration has green-lighted two new products designed to stop severe bleeding. Cresilon’s Traumagel received 510(k) clearance, meaning the agency approved it as a new medical device. The product, a plant-based gel that comes in a syringe, is designed to be inserted at the surface of a wound to stop “all types of bleeds,” according to Brooklyn, New York–based Cresilon. Meanwhile, Octapharma’s octaplasLG Powder, a lyophilized form of blood plasma, received an emergency use authorization that specifically allows military personnel to administer it when plasma is unavailable or impractical. The powder is a freeze-dried version of Octapharma’s pooled blood plasma, octaplas, which the FDA approved in 2013.

C&EN Global EnterpriseVol. 102(26)
Zero hunger
Openalex Percentile: Top 77%
Diverse Legal and Medical Studies
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FDA clears 2 treatments for emergency bleeding — Rowan Walrath · C&EN Global Enterprise (2024) | TGRS Research Map | TGRS