Aurie announced that the Aurie Reusable No-Touch Intermittent Catheter System has been granted marketing authorization from the 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 company said the system delivers single-use no-touch catheter features at a fraction of the cost.
Aurie also announced that Manu Varma has joined the company 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 Varma in a statement.
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.
