Sonoma Pharmaceuticals, Inc. announced on November 11, 2024, that it has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance is for its Microcyn technology-based hydrogel, which now features improved biocompatibility and an extended shelf life.
The new clearance permits Sonoma's Microdacyn® Hydrogel to be used under the supervision of a healthcare professional for a broader range of wound management. This includes wounds associated with dermal irritation, sores, injuries, and ulcers of dermal tissue.
Additionally, the hydrogel is now cleared for use on first and second-degree burns, diabetic ulcers, and for the management of mechanically or surgically debrided wounds. This expanded utility enhances the product's market applicability and competitive positioning.
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