RALEIGH, N.C., June 26, 2019 (Newswire.com) - UVision360, Inc, an innovative FemTech company, announced today the 510(k) clearance and launch of the Rigid LUMINELLE 360-degree Rotatable Disposable Sheath. This adds a second Disposable Sheath to the LUMINELLE DTx Hysteroscopy System product line. This new Sheath comes only 10 months after LUMINELLE’s initial FDA clearance for both hysteroscopy and cystoscopy.
Allison London Brown, Chief Executive Officer of LUMINELLE, said, “It is great to be a part of the resurgence of new technologies that can enable enhanced surgical techniques for the office. It’s our mission at LUMINELLE to create a better path for women and their physicians in the hysteroscopy and cystoscopy space. We understand from our physicians that hysteroscopy and cystoscopy devices are not a one-size-fits-all solution, and there is a strong unmet need to provide choices for patients and physicians when it comes to office operative and diagnostic procedures.”
The LUMINELLE DTx Hysteroscopy System, launched in early 2019, was designed with the goal of providing increased access to patient care in the office with a new solution for both physician and patient. From a patient standpoint, office-based systems may have the potential to lower out-of-pocket costs, and the LUMINELLE system may provide better comfort. The single-use Rotatable Sheath’s unique graduated tip size and dual fluid fenestrations can provide enhanced hydrodilation and allow for more comfortable traversing of the cervical canal. For the physician, the scope is equipped with a wide-angle, long depth of view lens with a Smart Focus Algorithm that automatically adjusts the focus and lighting during procedures and simplifies the process.
As the paradigm shift continues in the women’s health space, LUMINELLE is at the forefront striving to put control back in the hands of physicians and their patients. The LUMINELLE DTx Hysteroscopy System has the versatility to support numerous procedures in a cost-effective and efficient manner.
Name: Anna Bickley / Director of Business Operations
Company URL: www.LUMINELLE360.com
Address: 158 Wind Chime Ct, Ste. 201 Raleigh, NC 27615
LUMINELLE® and when image matters® are Registered Trademarks of UVision360, Inc.
Source: UVision360, Inc.