CNYBAC Client Aurie Receives FDA Safer Technology Designation for its Reusable Intermittent Catheter System
Published By: Aurie Oct 11, 2021
NEW YORK, October 11, 2021 — Aurie, a human-centered medical device company developing an automated reusable self-catheter system, announced today that the Aurie Reusable Intermittent Catheter System has received the Safer Technology designation from the U. S. Food and Drug Administration (FDA).
The FDA’s Safer Technologies Program (STeP), modeled on the principles and features of FDA’s Breakthrough Devices Program, was launched in January 2021. FDA believes that STeP will help patients have more timely access to medical devices and device-led combination products by expediting their development, assessment, and review. The Safer Technologies designation does not confer FDA marketing clearance or approval, but is given to devices that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program.
“The Aurie System’s inclusion in the FDA’s Safer Technologies Program is a testament to the need and potential of the Aurie System to offer people using intermittent catheters a more advanced, safer option,” said Aurie founder, Souvik Paul. “This designation will allow us to communicate regularly with FDA enabling us to better define our regulatory strategy and potentially accelerate our ability to bring the Aurie System to catheter users. “
Aurie raised $750K in funding in the fall of 2020 in a pre-seed round that was led by Lakehouse Ventures, a venture capital firm that supports founder-led companies during their earliest days of business formation and launch.
Aurie was also awarded two Small Business Innovation Research (SBIR) grants from the National Science Foundation and National Institute of Disability, Independent Living, and Rehabilitation Research. With this funding, Aurie built technical prototypes of the Aurie System and tested them in microbiology labs at the University of Notre Dame, and conducted human factors testing of interaction prototypes with catheter users in Houston, TX.
The promising results from this testing was reviewed by the FDA in consideration of Aurie’s Safer Technologies designation.
Aurie is a mission-driven human centered medical device company that partners with its community of users living with disabilities to co-design products that deliver on the promise of increased freedom and independence. Aurie was started after founder Souvik Paul’s sister-in-law sustained a spinal cord injury in a car accident. To learn more, visit www.livewithaurie.com.