FDA Clears Aurie Reusable Catheter for Up to 100 Uses

By Tom Whitfield

In May 2026, Aurie received FDA marketing authorization through the Class II De Novo pathway for a reusable intermittent catheter system designed for as many as 100 uses. The authorization covers the Aurie System, which pairs the Aurie Catheter with the portable Aurie Personal Disinfector.

Aurie described the decision as “the first reusable intermittent catheter system ever cleared for market,” a company claim that also establishes a new device classification for reusable catheter systems. At the School of Visual Arts, designer Souvik Paul presents Aurie in “Surround Presents”; the product grew from his thesis work.

What changes for people who use intermittent catheters?

The practical change is a repeatable preparation cycle: one catheter can serve as many as 100 uses, and each cleaning, disinfection and lubrication cycle takes 36 minutes with less than 30 seconds of user handling. That separates total device-processing time from the active time imposed on the user.

About 600,000 Americans rely on intermittent catheters six to eight times a day to urinate, representing roughly 3.6 million to 4.8 million daily catheterizations. Aurie notes that insurers can fail to cover enough catheters for beneficiaries, leaving some people to urinate less or reuse catheters.

The company states that standard single-use catheters carry a 50% annual chance of severe urinary tract infection, which it describes as a leading cause of death for people with spinal cord injuries. The announcement reports no comparative infection-rate result for Aurie; its measurable claims cover reuse count, 36-minute processing and less than 30 seconds of hands-on work.

How the system supports insertion and hygiene

• Polished eyelets are intended to prevent urethral trauma.
• A tip-end eyelet is designed to maximize emptying, while a proprietary articulating support handle helps stabilize the catheter in the body and prevents slippage during insertion.
• The insertion sleeve and introducer tip protect the catheter from grime and germs during insertion, supporting catheterization away from a clinical setting.
• The company states that the catheter components contain neither phthalates nor BPA.

The no-touch architecture depends on the sleeve, introducer and disinfector working as one sequence rather than as separate accessories. The Personal Disinfector cleans, disinfects and lubricates the catheter in 36 minutes; the user spends less than 30 seconds of their own time on the cycle.

Aurie says it is designing catheter reuse to be “as easy as throwing a single-use catheter away.” That phrase defines the company’s intended convenience benchmark: a reusable workflow that approaches the familiarity of disposing of a single-use catheter.

From ultraviolet prototype to De Novo authorization

Paul’s first thesis prototype was a handheld device that sterilized catheters with ultraviolet light. After nearly a decade of iteration, the concept evolved into the Aurie System, a reusable, no-touch catheter system.

Aurie also maintains a regularly updated company blog covering catheter and urinary tract infection research alongside company news. The May 2026 De Novo authorization places the decade-long development on a market pathway, with the company calling the reusable-system classification a first.

Where deployment begins

Aurie will launch at Veterans Health Administration spinal cord injury hospitals in early 2027. The announcement identifies a specific institutional setting and date; it does not state a broader release schedule.

The next measurable checkpoint is the early 2027 hospital rollout. It will place the stated 36-minute cycle and 100-use limit within spinal cord injury care routines.