FDA Approves Expanded Sterilization and Disinfectant Methods for the LUMINELLE® DTx System

UVision360, Inc., an innovative medical device company, announces today that the U.S. Food and Drug Administration (FDA) has approved the Company's expanded reprocessing procedures for use with the LUMINELLE DTx System. This expansion will allow the LUMINELLE DTx System to be more fully utilized in broader settings such as Hospital Systems and Outpatient Surgical Centers. It will also support practices that are moving to these newer reprocessing methods. 

The newly approved reprocessing methods include the Steris® Revital-Ox® RESERT® HLD as a high-level disinfectant method and the Steris® V-PRO® Low Temperature Sterilization as a sterilization method for the LUMINELE DTx System. Currently, Metricide® OPA Plus high-level disinfectant and Anderson Scientific's Flexible Bag Ethylene Oxide sterilization are approved for the LUMINELLE DTx System. Because of this new sterilization method, UVision360 will soon be launching a new version of the LUMINELLE System.

"When we developed the LUMINELLE DTx System, we wanted to create a platform that is easy to use in any setting – Physician Office or Operating Room and for a variety of uterine and urologic procedures. And not only straightforward for physicians to use, but also trouble-free for staff and nurses to clean and manage, while comfortable for patients to tolerate," said UVision360 CEO Allison London Brown. "With patient safety top of mind, especially during Covid, we wanted to make sure that cleaning and sterilization of the system is compatible with the latest technologies. The simple design of our system avoids the lumens and channels of many other reusable endoscopy systems, therefore improving the ability for our Scope to be easily cleaned and reducing the chances of contamination. 

About the LUMINELLE DTx System 

The LUMINELLE DTx System is FDA cleared for both diagnostic and therapeutic hysteroscopy and cystoscopy. Health professionals can perform office evaluations and treatments of the uterus and bladder pathologies without a prohibitive investment in equipment. Moreover, the LUMINELLE DTx System not only provides convenience to office staff and patients but cost savings as well, while also addressing the concerns associated with current disposable devices on the market. 

About UVision360 

UVision360, Inc. is dedicated to advancing access to care for women in the operating room or through transitioning procedures to their physician's office. The company has created the LUMINELLE DTx System, a simplified, compact, and modular endoscopic system employing the latest in high-tech optics and interchangeable accessories to meet the needs of physicians and patients.