Aurie Gets FDA Clearance for Reusable Catheter System

Aurie, a Syracuse-based medical device startup, has received FDA clearance for its reusable, self-cleaning catheter system, ending a near-decade development cycle. The clearance allows the company to market its no-touch intermittent catheter and portable disinfection unit nationwide, with first sales targeted for November. The system is a notable departure from the single-use status quo in intermittent catheterisation, where cost and infection risk have long sat in tension.

Aurie’s system pairs a no-touch intermittent catheter, where the user never handles the section that enters the body, with a portable machine that automatically cleans and disinfects between uses. Each catheter can be used up to 100 times before disposal, addressing a long-standing trade-off in the market. Safer no-touch catheters typically cost $5 to $10 each and are not always fully covered by insurance, leading some users to reuse devices that were never designed for it.

Founder and CEO Souvik Paul said the clearance lets the company engage clinicians on scientific evidence rather than concept alone. Initial market entry will be through Veterans Affairs hospitals that treat spinal cord injury patients, a group particularly vulnerable to urinary tract infections that can escalate into hospitalisation or sepsis. Final assembly will take place in Florida, with most components sourced domestically.

The company has raised more than $8 million in private investment and more than $5 million in federal grants since relocating to Syracuse in 2019, and currently employs seven people.

With FDA clearance now secured, Aurie’s challenge shifts from regulation to commercial execution and clinical adoption, particularly among prescribers concerned about reuse risk. Expect close attention from the wider urology and infection prevention market, where the economic case for reusable, self-cleaning consumables has been building for years but has rarely cleared the regulatory bar in this category.