Aurie Receives FDA De Novo Grant for Reusable Intermittent Catheter System

Aurie has received FDA marketing authorisation through the Class II De Novo pathway for its Reusable No-Touch Intermittent Catheter System, creating a new device classification for reusable intermittent urinary catheter systems.

The authorisation is notable in a category that has long depended on single-use intermittent catheters. Aurie’s system is designed to offer a reusable alternative while maintaining no-touch handling features and automated reprocessing between uses.

The system includes a no-touch intermittent catheter intended for up to 100 uses, a portable catheter washer-disinfector and pre-packaged supply pods. According to the company, testing across microbiology and human factors demonstrated reasonable assurance of safety and effectiveness for the system’s intended use.

The initial launch is expected later this year within Veterans Health Administration spinal cord injury hospitals. This setting provides a focused entry point, as intermittent catheterisation is an important part of bladder management for many patients with spinal cord injury.

From a clinical workflow perspective, the system aims to reduce the dependence on large volumes of disposable catheters while supporting cleaner handling during use. Its automated cleaning, disinfection and lubrication process may also help address practical barriers that have limited catheter reuse in the past.

The regulatory pathway is commercially important because the De Novo grant establishes a classification route for future reusable catheter systems. This could shape how similar technologies are evaluated as manufacturers look to balance safety, usability, cost and sustainability.

Aurie also announced leadership updates, including the appointment of Manu Varma as an independent board director, Dr. Christopher Elliott to its Scientific Advisory Board, and the promotion of Sergey Grigoryants to Chief Technology Officer.