Aurie Received FDA De Novo Grant for First Automated Safely Reusable Intermittent Urinary Catheter System
On 11 May 2026, Aurie announced that its Aurie Reusable No-Touch Intermittent Catheter System™ had received marketing authorization from the U.S. Food and Drug Administration (FDA) through the Class II De Novo pathway. This approval established it as the first reusable intermittent urinary catheter system and created a new device classification in a market that had relied exclusively on single-use catheters for decades. The company stated that the Aurie System was expected to be launched in Veterans Health Administration spinal cord injury hospitals later that ...
