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
- Rowan Walrath
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