Aurie Receives FDA De Novo Grant for First Automated Safely Reusable Intermittent Urinary Catheter System

Company announces appointment of Manu Varma to Board of Directors, Dr. Christopher Elliott to Scientific Advisory Board, and Sergey Grigoryants to Chief Technology Officer

SYRACUSE, N.Y., May 11, 2026 /PRNewswire/ -- Aurie announced that the Aurie Reusable No-Touch Intermittent Catheter System™ has been granted marketing authorization from the U.S. Food and Drug Administration (FDA) through the Class II De Novo pathway—establishing it as the first ever reusable intermittent urinary catheter system and creating a new device classification in an industry that exclusively relied on single-use catheters for decades. The Aurie System is slated to launch into the Veterans Health Administration spinal cord injury hospitals later this year.

The Aurie System includes: a 100-use no-touch intermittent catheter; a portable catheter washer-disinfector; and pre-packaged supply pods. The system delivers single-use no-touch catheter features at a fraction of the cost. 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.

Manu Varma Joins Board of Directors

Manu Varma joins Aurie as an independent Board Director. He brings more than two decades of chronic care leadership, most recently as President of North America at Coloplast, where he oversaw several business lines, including its largest market for intermittent catheters.

"Aurie is addressing the industry's biggest challenge by combining sustainability and user-centered design to define a new standard of care. 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," said Manu Varma

Dr. Christopher Elliott Joins Scientific Advisory Board

Christopher S. Elliott, MD, PhD joins Aurie's Scientific Advisory Board. Dr. Elliott is a leading voice for sustainable alternatives to single-use catheters and a Clinical Associate Professor of Urology at Stanford University.

Sergey Grigoryants Promoted to Chief Technology Officer

Sergey Grigoryants has been promoted from Vice President of Engineering to Chief Technology Officer. He will oversee the company's technology roadmap, including infection-detecting sensor-enabled catheters.

About Aurie

Aurie is a medical device company that has developed the first safely⁺ reusable no-touch intermittent catheter system. Aurie has been supported by Lakehouse Ventures, among others. Learn more at livewithaurie.com.

⁺When used in accordance with the Instructions for Use.

SOURCE CathBuddy, Inc.