FDAnews Device Daily Bulletin

Z-Medica Gets FDA Clearance for Internal Bleeding Control Device

July 14, 2017

The FDA awarded de novo clearance to Z-Medica’s QuickClot Control+ device.

The device is indicated for temporary control of internal organ space bleeding for patients with Class III or IV bleeding, according to the Wallingford, Conn., company. Preclinical trials for the device, they said, showed the device led to significantly less blood loss compared to packing with laparotomy sponges.

The new device will aid trauma and operating rooms in stabilizing severely injured patients. The approval comes seven months after the company reached a three-year deal to supply the New York Police Department with its QuikClot belt trauma kits.

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