www.fdanews.com/articles/203426-axio-biosolutions-gets-fda-510k-clearance-for-hemostatic-axiostat-patch
Axio Biosolutions Gets FDA 510(k) Clearance for Hemostatic Axiostat Patch
July 2, 2021
India-based Axio Biosolutions has received FDA 510(k) clearance for its hemostatic Axiostat patch.
The patch, which previously earned CE mark certification, is for controlling moderate-to-severe bleeding in vascular procedures and at the sites of surgical debridement and punctures.
The Axiostat patch has bioadhesive properties that provide a strong mechanical barrier at the site of an injury, keeping out bacteria and reducing recovery time.