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Aurie announces authorization, appointments

Aurie announces authorization, appointments

SYRACUSE, N.Y. – Aurie has 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. The company says the authorization establishes the product as the first ever reusable intermittent urinary catheter system and creates a new device classification in an industry that has 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. “Aurie is addressing the industry’s biggest challenge by combining sustainability and user-centered design to define a new standard of care,” said Manu Varma, who is joining the company as an independent board director. “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.” Varma 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 has also announced that:

  • Dr. Christopher Elliott, a clinical associate professor of urology at Stanford University, has joined the company’s Scientific Advisory Board; and
  • Sergey Grigoryants has been promoted from vice president of engineering to chief technology officer to oversee the company’s technology roadmap, including infection-detecting, sensor-enabled catheters.

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