LUMINELLE news
A new biopsy sheath developed by Raleigh med tech startup UVision360 is ready to hit the market after landing federal approval this week.
UVision360 announced it had received the greenlight from the U.S. Food and Drug Administration for its patented LUMINELLE 360° Bx Sheath.
The device expands the startup’s “all-in-one” gynecological system LUMINELLE DTx, an endoscopic platform that enables diagnostic and operative procedures, such as uterine
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 reprocessin
UVision360, Inc., an innovative medical device company, announces today that the U.S. Food and Drug Administration (FDA) has approved the patented LUMINELLE 360° Bx (Biopsy) Sheath which expands the capability of the LUMINELLE® DTx System. The LUMINELLE 360° Bx sheath, combined with the LUMINELLE DTx System, is the first and only integrated directed biopsy device not requiring the use of additional instruments, and indicated for uterine and bladder biopsie
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 H
UVision360, Inc., an innovative FemTech company, announces today that the United States Patent and Trademark Office has issued a system method patent, No.10926059, for the Company`s LUMINELLE® DTx System (LUMINELLE).
The new patent allows UVision360 to protect the method of assembly and manufacturing of the LUMINELLE system and sheaths with a rotatable function and includes a variety of manufacturing techniques and technologies that would be required to manufacture a dev