UVision360’s Hysteroscopy System Receives 510(k) Clearance

UVision360’s Luminelle DTx system, a hysteroscopy device, received 510(k) clearance by the FDA for use in hysteroscopy and cystoscopy procedures.

The device allows physicians to examine the internal lining of the uterus and identify suspicious tissue, in addition to allowing biopsies under visualization.

The system is similar to operating room equipment but can be used by physicians to perform the procedures in their offices.