Machina Medical, Corp. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for MFUSE, a sterile, single-use medical device indicated for the temporary external control of moderate to severe bleeding.

MFUSE is designed to support clinicians in managing external bleeding by forming a flexible hydrogel barrier when applied to the wound site. The device is intended to provide temporary stabilisation of bleeding to allow time for definitive medical intervention.

“FDA clearance of MFUSE represents an important milestone for Machina Medical and reflects years of focused development and regulatory rigour,” said Bill Southwick, Chief Executive Officer of Machina Medical. “MFUSE was designed to address real challenges care teams face when managing external bleeding, particularly in high-acuity situations where time, simplicity, and control are critical.”

When applied, MFUSE forms a flexible hydrogel barrier that adheres to tissue and creates a mechanical barrier to bleeding. As indicated, MFUSE can be removed using normal saline or sodium bicarbonate solution.

“With MFUSE now FDA-cleared, we are preparing for a phased commercial introduction in the United States, with initial availability focused on hospital and emergency care settings,” said David Wittwer, Executive Vice President of Operations at Machina Medical.