FDA grants de novo authorization to Aurie Reusable Intermittent Catheter System

The FDA has granted de novo marketing authorization to the Aurie Reusable No-Touch Intermittent Catheter System, marking the first ever reusable intermittent urinary catheter system and establishing a new device classification category for reusable intermittent catheter technology, the company announced in a news release.¹

The device is indicated for the drainage of urine from the bladder of adult male patients requiring intermittent catheterization. The FDA emphasized that the system must be cleaned, high-level disinfected, and lubricated with Aurie Personal Washer-Disinfector prior to use.²

"Aurie is addressing the industry's biggest challenge by combining sustainability and user-centered design to define a new standard of care,” said Manu Varma, an independent board director for Aurie, in the news release.¹ “The de novo clearance is a major milestone, and I'm excited to work with this team as they take the business to the next level.”

According to the company, the system is expected to launch within Veterans Health Administration spinal cord injury hospitals later in 2026.

About the device

The Aurie System includes a reusable no-touch intermittent catheter intended for up to 100 uses, a portable catheter washer-disinfector, and prepackaged supply pods. The automated portable reprocessing device is designed to clean, disinfect, and lubricate the catheter between uses. The no-touch handling features are intended to reduce contamination during insertion.

The company stated that “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.”

Aurie previously received FDA Safer Technologies Program (STeP) designation for the system, a pathway intended to facilitate development of devices that may significantly improve safety relative to currently available options.³

REFERENCES

1. Aurie receives FDA de novo grant for first automated safely reusable intermittent urinary catheter system. News release. CathBuddy, Inc. May 11, 2026. Accessed May 11, 2026. https://www.prnewswire.com/news-releases/aurie-receives-fda-de-novo-grant-for-first-automated-safely-reusable-intermittent-urinary-catheter-system-302767331.html

2. Classification order. US Food & Drug Administration. Accessed May 11, 2026. https://www.accessdata.fda.gov/cdrh_docs/pdf25/DEN250023.pdf 

3. Aurie Update: SBIR and Safer Technologies Program! News release. Aurie. October 11, 2022. Accessed May 11, 2026. https://www.livewithaurie.com/article/safer-technologies-program