A reusable no-touch catheter system that the FDA had to invent a new device category for. Eight years of stubborn design from a Syracuse warehouse.
FIG 01. The Aurie System - one catheter, one portable disinfector, ninety-nine fewer disposable tubes in the bin. Photographed by the company, undated.
Picture a desk somewhere in upstate New York. On it sits a portable device about the size of a hardcover novel. A catheter goes in. Thirty seconds of human attention is spent. Thirty-six minutes later the same catheter comes out cleaned, high-level disinfected, lubricated, ready to be used again. Up to one hundred times.
This is the daily routine inside Aurie. It looks unremarkable until you remember that for the last fifty years the catheter industry has been built on a single, billable premise: throw it away and order another one. Aurie's premise is the opposite, and in May 2026 the U.S. Food and Drug Administration agreed with it - granting the company a De Novo marketing authorization and establishing, in the process, a brand-new device classification category for reusable intermittent urinary catheters.
The thing about creating a category is that no one was looking for one. Single-use was the answer everyone had stopped questioning. Aurie questioned it.
Souvik Paul did not set out to start a medical device company. He was at Johnson & Johnson, designing consumer medical products, with side credits including work shown at the Cooper Hewitt Smithsonian Design Museum. Then his sister-in-law sustained a spinal cord injury, and her insurance refused to cover the number of intermittent catheters she actually needed.
She did what hundreds of thousands of people quietly do: she reused single-use catheters that were never engineered for reuse. She got infections.
Paul left J&J. He pulled in a urologist (Daniel Wollin, MIT-trained), a medical device operator with seventeen years at the bench (Marjorie Nelson), and an engineer who had spent twenty years and six patents at Becton Dickinson and Boston Scientific (Sergey Grigoryants). He started a company once called CathBuddy, now called Aurie. Eight years later, the device works, the regulators agree, and the first stop is the U.S. Veterans Health Administration.
Aurie ships as a system. Not a catheter, not a gadget - a system. Take either piece away and the math falls apart.
No-touch design. Polished eyelets so tissue isn't snagged. An articulating support handle for hands that don't grip the way clinicians assume they do. Phthalate-free. BPA-free. Built to be reused up to 100 times.
Portable washer-disinfector. Cleans, high-level disinfects, and lubricates the catheter in roughly 36 minutes. The user is in and out in under thirty seconds.
Pre-packaged consumables for the reprocessing cycle. The boring, important consumable layer that makes the whole thing repeatable.
Intermittent catheters are used by people with spinal cord injuries, multiple sclerosis, spina bifida, and other causes of neurogenic bladder. The standard of care quietly assumes a new sterile tube every time. The actual lived experience is: people run out, people reuse, people get UTIs.
A purpose-built reuse protocol replaces unsanctioned reuse. Peer-reviewed antimicrobial testing supports the cycle.
One Aurie catheter substitutes for as many as a hundred single-use ones. The packaging math is even better.
Paul's stated goal: the system priced so insurance will cover it - parity with current single-use catheter spend.
Designed with a user advisory board carrying 20+ combined years of catheter experience. Real hands, real feedback.
Industrial designer and design strategist. Cooper Hewitt Smithsonian-recognized. Former J&J consumer medical devices. Started Aurie after a family member's catheter-related infections.
Seventeen-plus years in medical devices. Has led commercial launches across multiple device categories - the operator with the receipts.
Practicing urologist, 10+ years focused on urinary tract disease. MS in Engineering and Management from MIT. Bridges the clinic and the workshop.
Company founded (originally as CathBuddy, Inc.) after a personal encounter with the limitations of single-use catheterization.
Human factors validation studies of the Aurie Reusable Catheter System usability and operations procedures (catalogued in the KT Casebook, 9th Edition).
$6M Seed round closes, backed by Australian disability tech accelerator Remarkable Tech among others.
Peer-reviewed antimicrobial testing of the catheter and reprocessing device published.
FDA grants Class II De Novo marketing authorization. A new device classification category is created.
Planned commercial launch into Veterans Health Administration spinal cord injury hospitals.
Led/backed by Remarkable Tech, the Australian disability tech accelerator, alongside undisclosed co-investors.
Across earlier pre-seed and seed instruments. Steady, patient capital - the kind regulatory science actually requires.
First commercial deployment, into SCI hospitals.
Accelerator alumnus and ecosystem partner.
Innovation Insights collaborator on disability-centered design.
The machine takes 36 minutes. You take 30 seconds. Aurie spent eight years to make that ratio possible.
The original incorporated name. The rebrand arrived on the road to FDA clearance.
Over twenty combined years of catheter use among its members. Co-design is not a slogan here.
Founder Souvik Paul's design work has been displayed at the Cooper Hewitt Smithsonian Design Museum.
Return to that desk in upstate New York. The portable disinfector is humming. Inside is a catheter that, a year ago, was not legal to put back in a human being. Today, on the strength of an FDA category that did not exist last summer, it is.
Soon that same machine will sit on a nightstand inside a Veterans Health Administration spinal cord injury unit. A veteran who has spent years ordering plastic tubes by the case will use one device, again and again, for a hundred days at a stretch. The trash bag will be lighter. The infection risk, on the evidence so far, will be lower. The insurance bill, by design, will not be higher.
That is what changed: not the catheter, exactly. The assumption underneath it. Aurie's bet is that once you change an assumption, you don't have to argue it anymore. You just ship the machine.