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Axiostat is India ’ s first entry on the U.S. hemostat market
Indian medical device maker Axio Biosolutions became the first Indian company with a wound care product cleared by the FDA, according to a press release from the company posted yesterday. The federal watchdog granted 510(k) clearance to Axio’s Axiostat chitosan hemostatic dressing, which is cleared as an over-the-counter product to stop external bleeding. The dressing is designed to stop uncontrollable bleeding within two to three minutes of application, and is used by the Indian armed forces, the company said. “The FDA clearance of Axiostat in the US is a major milestone in our journey so far. This is a valida...
Source: Mass Device - March 1, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Blood Management Regulatory/Compliance Wound Care axiobiosolutions Source Type: news