ROSWELL, Ga., Jan. 20, 2026 (GLOBE NEWSWIRE) -- Machina Medical, Corp. today 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 stabilization 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 rigor,” 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.
MFUSE is indicated for temporary external use for controlling moderate to severe bleeding.
About Machina Medical
Machina Medical, Corp. is a U.S.-based medical device company focused on developing solutions for bleeding control and wound management. Founded by clinicians and operators with experience in high-acuity care environments, the company applies novel materials and thoughtful design approaches to address gaps in external bleeding management.
For more information, visit www.machinamedical.com.
Media Contact:
Name: Tiffini Wittwer, MPH
Email: tiffini@machinamedical.com
Phone: +1 707 799 6732
