FDA Clears MFUSE: A New Hydrogel Device to Stop Severe Bleeding

ROSWELL, GA – January 20, 2026 – Machina Medical, Corp. has received 510(k) clearance from the U.S. Food and Drug Administration for MFUSE, a single-use device designed for the temporary external control of moderate to severe bleeding. The clearance, logged under number K250319, positions the company to enter the competitive multi-billion dollar hemostasis market with an innovative solution aimed at one of the most critical challenges in emergency medicine.

MFUSE is designed to form a flexible hydrogel barrier when applied directly to a wound. This barrier adheres to the tissue, creating a mechanical seal to stop blood flow. The technology is intended to provide rapid, temporary stabilization, buying crucial time for clinicians to administer definitive medical care. This clearance marks a major milestone for the Roswell-based company, validating years of development and rigorous regulatory review.

“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, in a statement. “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.”

A New Approach to a Critical Problem

Uncontrolled hemorrhage is a leading cause of preventable death in trauma victims, with severe injuries capable of causing fatal blood loss in minutes. For decades, first responders and emergency physicians have relied on tools like tourniquets and hemostatic dressings impregnated with agents like kaolin or chitosan to accelerate the body’s natural clotting process.

Machina Medical’s MFUSE takes a different approach. The device is classified by the FDA as a “Hemostatic Wound Dressing Without Thrombin Or Other Biologics,” and its hydrogel-based mechanism works independently of the body’s intrinsic clotting cascade. This is a significant feature, as it suggests the device could be effective even in patients whose clotting ability is compromised, such as those on anticoagulant medications or suffering from hypothermia.

When applied, MFUSE rapidly forms a seal that physically obstructs blood flow. The company highlights that its nature-inspired solution can achieve hemostasis in under 30 seconds, a critical time saving in life-threatening situations. This speed and coagulation-independent action address a long-standing need in emergency care.

“In the field, you're in a race against time. Every second counts,” noted an experienced paramedic not affiliated with the company. “A tool that can be applied quickly and works reliably, regardless of the patient's condition, has the potential to be a true game-changer. Simplicity and speed are what save lives before a patient even reaches the hospital.” The device's design also considers removal, a key clinical consideration; the hydrogel can be dissolved and irrigated from the wound using standard sterile saline or a sodium bicarbonate solution.

Navigating a Competitive Market

The FDA clearance allows Machina Medical to enter a robust and growing global market for hemostasis products. Valued at over $4.7 billion in 2023, the hemostats market is projected to nearly double to $9.3 billion by 2032, driven by an increasing volume of surgeries and a rising incidence of trauma. North America currently dominates this market, accounting for a substantial share due to its advanced healthcare infrastructure and strong focus on trauma preparedness.

MFUSE will compete with established products from major players, including the kaolin-based QuikClot and the chitosan-based Celox. These products have been mainstays in military and civilian emergency kits for years. However, MFUSE’s distinct hydrogel mechanism and rapid action provide a clear point of differentiation. By offering a solution that does not rely on pro-coagulant minerals or biological materials, the company is positioning its device as a next-generation alternative.

The 510(k) regulatory pathway requires a manufacturer to demonstrate that its product is “substantially equivalent” to a legally marketed predicate device in terms of safety and effectiveness. By successfully navigating this process, Machina Medical has established MFUSE as a credible and viable option for its intended use in controlling external hemorrhage.

From Lab to Lifesaving: The Path to Market

Machina Medical was founded by a team of clinicians and operators with direct experience in high-acuity care environments, a background that has heavily influenced its product design philosophy. The company's focus on addressing practical gaps in bleeding management is evident in MFUSE's emphasis on simplicity and rapid deployment.

With regulatory approval secured, the company is now turning its attention to commercialization. According to David Wittwer, Executive Vice President of Operations, the plan involves a phased introduction in the United States. “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,” Wittwer stated.

This strategy targets the environments where the device can have the most immediate impact—emergency departments, operating rooms, and ambulances. These settings are staffed by professionals trained to handle advanced medical technologies and are constantly seeking more effective tools to manage severe trauma. By focusing on these key institutional customers first, the company can build a strong foundation of clinical use and gather real-world data on the device's performance before a wider rollout.

As MFUSE begins to enter these critical care settings, its performance will be closely monitored by the medical community. The device's ability to quickly and effectively control severe bleeding in real-world trauma scenarios will ultimately determine its success and its potential to become a new standard of care. For the clinicians on the front lines and the patients they treat, the introduction of a new tool that promises to save precious seconds when lives are on the line is a welcome development.