Posted by Michael Wonder on 10 Mar 2021
U.S. FDA accepts UVision360 submission for novel Luminelle DTx system biopsy sheath
9 March 2021 - UVision360 announces today that the U.S. FDA has accepted the Company's submission to expand the Luminelle DTx System portfolio to now include the Luminelle 360° 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° 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.
