Uvision360 Receives Third FDA Clearance

UVision360, creators of the patented LUMINELLE DTx Hysteroscopy System, announced today the 510(k) clearance and launch of the latest addition to the LUMINELLE line, the 3mm LUMINELLE Dx 360˚ Rotatable Disposable Sheath (Diagnostic).

This new attachment expands the LUMINELLEDTx Hysteroscopy System portfolio with a simple solution for diagnostic hysteroscopy and cystoscopy office procedures, complementing its current operative capabilities.

Allison London Brown, Chief Executive Officer of UVision360, said, “With LUMINELLE, our goal is to champion the treatment paradigm shift in Femtech and women’s uterine and urinary health. No two patients are alike, and the majority of women prefer the office environment for a more comfortable experience. With the latest addition to the LUMINELLE sheath portfolio, our system continues to provide physicians the choices needed to perform a multitude of procedures with clarity, ease, and economic value while in the comfort of the office.”

The LUMINELLE System utilizes advanced technology that provides a simplified solution with HD optical clarity by means of its wide-angle lens, long depth of view and a proprietary Smart Focus Algorithm that auto-adjusts focus and lighting during procedures.  The Single-Use Sterile Sheath portfolio enables easier cleaning and reduces workflow. Leveraging all these elements, the new LUMINELLE Dx 360-degree Rotatable Disposable Sheath (Diagnostic) measures only 3mm in diameter, allowing for easier utilization and greater patient comfort. The sheath’s small diameter possesses the potential to reduce the need for anesthesia, benefiting both physician and patient alike.

The LUMINELLE DTx Hysteroscopy System, launched in early 2019, was designed to provide increased access to office solutions for physicians, practices and patients. With this best-in-class system, small enough to fit in any patient room, LUMINELLE now offers a growing range of customizable solutions to address the growing office hysteroscopy and cystoscopy market.-NS Medical Devices

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