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E., Stokes, S., McKenzie, S., Nilles, E

Neuropsychiatric aspects of treated Wilsons disease

Comment: With respect to the newness criterion at 419.66(b)(1), the applicant reiterated that the VersaVue TM Single-Use Flexible Cystoscope received 510(k) clearance from FDA on October 6, 2023, and that it submitted an application for pass-through status on February 11, 2025, which is within 3 years of the initial market authorization

This case experience reflects what the mechanism and literature already suggest: endogenous stimulation can be a viable, practical option for men with low testosterone, as well as a valuable adjunct for those already on TRT who wish to preserve fertility