Usmima’s Mowoot II Intestinal Device Designated a Breakthrough by FDA
Barcelona, Spain-based device developer Usmima has received the FDA’s Breakthrough Device designation for its first product, the Mowoot II intestinal transit management system for treatment of neurogenic bowel disorder.
The patented Mowoot II device works by delivering intermittent, wave-like pressure on the abdomen, like a manual massage.
The FDA grants breakthrough device status to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
The new designation “validates our belief that our solution offers significant advantages over existing approved or cleared alternatives,” said Usmima CEO Markus Wilhelms.