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U.S. Food and Drug Administration Accepts UVision360, Inc. Submission for Novel LUMINELLE DTx System Biopsy Sheath

March 9, 2021

Via: BioSpace

UVision360, Inc., an innovative FemTech company, announces today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s submission to expand the LUMINELLE DTx System portfolio to now include the LUMINELLE 360° Bx (Biopsy) Sheath. The LUMINELLE DTx System, is a compact hysteroscopy and cystoscopy system, designed to meet the needs of patients and physicians in the office setting. The novel and patented LUMINELLE 360° Bx (Biopsy) sheath combined with the LUMINELLE Scope, will be the first and only visually directed endometrial biopsy system not requiring the use of additional instruments.

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