In Brief: Bioetica
This article was originally published in The Gray Sheet
Bioetica: FDA approves PMA for firm's Hemostagene absorbable hemostatic sponge for use in controlling moderate bleeding in surgery and wound treatment. MedChem has U.S. rights to the product ("The Gray Sheet" April 17, In Brief) and expects to introduce the device in late October under the brand name Avifoam. Bioetica's PMA was based on clinical data from a 300-patient multicenter trial evaluating Hemostagene to aid "hemostasis when control by ligature or conventional procedures is ineffective or impractical," the firm states...
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