The Aurie System Receives FDA Clearance as the first-ever Safely Reusable Catheter System!

We're incredibly excited to announce 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 early next 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.

In addition to the planned VA launch, we're working to get the Aurie System covered by major insurance providers — at no more than what they already pay for single-use catheters.

The Aurie System has three components that work together to let you safely reuse each Aurie Catheter up to 100 times - the Personal Washer-Disinfector, Monthly Supplies, and the Catheter. The proposed manufacturer list pricing* below mirrors the cost of the single-use no-touch catheters it replaces**:

1. Aurie Personal Washer-Disinfector: $2,587 (one-time cost or 13-month capped rental at $199 per month)

2. Monthly Supplies: $225 per month

3. Aurie Catheter: $489 per 100x use catheter

*Proposed manufacturer list pricing; final pricing through your DME supplier may vary.

**Medicare currently recognizes $9.99 as the price of single-use "no-touch" catheters and closed catheter systems. For someone using 2,400 catheters per year, that adds up to roughly $24,000.