FDA grants Breakthrough Designation to intestinal management system (Medtech News)

Dr. Markus Wilhelms, CEO and co-founder of MOWOOT, said: “The Breakthrough Device Designation is a significant milestone for our company and validates our belief that our solution offers significant advantages over existing approved or cleared alternatives, per FDA requirements. Our clinical results show clear benefits for severely constipated patients, and we look forward to working with the FDA to introduce our technology to the US market as quickly as possible to improve bowel management in patients with neurogenic bowel disorders, for better patient outcomes and reduced healthcare expenditures.”