LUMINELLE® DTx System Applies to FDA for Expanded Reprocessing, Improves Offering for OR and Patient Safety
Opens Door to Elective Surgical Procedures Restricted by COVID-19
RALEIGH, N.C., March 16, 2021 /PRNewswire/ -- UVision360, Inc., an innovative FemTech company, announces today that the U.S. Food and Drug Administration (FDA) has accepted the Company's submission for expanded reprocessing procedures for use with the LUMINELLE DTx Hysteroscopy System.
Supported by STERIS® Device Testing procedures, UVision360, Inc. is adding the Revital-Ox® RESERT® HLD as a high-level disinfectant method and the V-PRO® Low Temperature Sterilization as a sterilization method for the LUMINELE DTx Hysteroscopy System. Currently, Metricide® OPA Plus high-level disinfectant and Anderson Scientific's Flexible Bag Ethylene Oxide sterilization are approved for the LUMINELLE DTx System. With this new Sterilization method, UVision360 will be launching a new version of the LUMINELLE System.
"While COVID-19 has limited how and when women can be treated for a variety of health concerns, LUMINELLE has been energetically working to give patients and physicians a wider range of accessibility options. Whether in the office or the operating room, LUMINELLE will be poised to support them with new reprocessing options. With patient safety top of mind and given the flexibility of our LUMINELLE DTx System to be deployed in both an operating room and a doctor's office, we wanted to make sure that cleansing and sanitization of the system is compliant with the latest technologies," said UVision360 CEO Allison London Brown. "We feel confident that the expanded sterilization procedures will make it easier for doctors and hospitals to adopt and utilize our the LUMINELLE DTx System."
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. More information about the LUMINELLE DTx Hysteroscopy System can be found by contacting [email protected] or visiting www.luminelle360.com
SOURCE UVision360, Inc
Share this article