domingo, 13 de diciembre de 2015

Wound dressing approved for civilian use | Drug approval case studies | Device cybersecurity workshop

FDA Medical Countermeasures Initiative Update

FDA clears military traumatic wound dressing for use in the civilian population

On December 7, 2015, FDA cleared the use of the XSTAT 30 wound dressing, an expandable, multi-sponge dressing used to control severe, life-threatening bleeding from wounds in areas that a tourniquet cannot be placed (such as the groin or armpit) in battlefield and civilian trauma settings. The clearance expands the device’s indication from use by the military only to use in adults and adolescents in the general population. 

Early control of severe bleeding may prevent shock and may be life-saving. According to the United States Army Institute of Surgical Research, 30 to 40% of civilian deaths by traumatic injury are the result of hemorrhaging. Of those deaths, 33 to 56% occur before the patient reaches a hospital.
The device is available in packages of one or three syringe-style applicators containing 92 compressed, cellulose sponges that have an absorbent coating. The sponges expand and swell to fill the wound cavity, creating a temporary physical barrier to blood flow.
Read the FDA press release

Related information

Drug Approval Case Studies

FDA Drug Approval Case Study thumbnailNew learning tool
FDA has introduced a new learning tool, Drug Approval Case Studies, for patients and patient advocacy groups, health professionals, small business, and pharmaceutical and clinical innovators designed to advance knowledge of drug regulatory processes.
Read FDA’s first case study in this series Drug Approval: Bringing a New Drug to the Market (PDF, 637 KB) to learn how to navigate the drug approval process from conducting nonclinical testing and clinical trials to submitting a new drug application to FDA.

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In case you missed it:
  • Watch a new FDA Drug Info Rounds video (3:01) on Breakthrough Therapy designation - related: Breakthrough Therapies fact sheet (December 1, 2015)

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