SYRACUSE, N.Y., May 11, 2026 /PRNewswire/ — Aurie announced that the Aurie Reusable No-Touch Intermittent Catheter System™ has been granted marketing authorization from the U.S. Food and Drug Administration (FDA) through the Class II De Novo pathway—establishing it as the first ever reusable intermittent urinary catheter system and creating a new device classification in an industry that exclusively relied on single-use catheters for decades. The Aurie System is slated to launch into the Veterans Health Administration spinal cord injury hospitals later this year.

The Aurie System includes: a 100-use no-touch intermittent catheter; a portable catheter washer-disinfector; and pre-packaged supply pods. The system delivers single-use no-touch catheter features at a fraction of the cost. Rigorous testing—from microbiology to human factors—demonstrated the reasonable assurance of safety and effectiveness for the intended use of the Aurie System⁺ and set the standard for all reusable catheter systems to come.