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On July 1, 2024, FDA granted the applicant Special 510(k) clearance for the LithoVue TM Elite Ureteroscope (with pressure monitoring) with a redesigned distal tip to improve its durability during a ureteroscopy for this same indication

Therefore, although 6-hydroxy-FAD actually acts a dual role as an active cofactor for FSP1 and a potent antioxidant in vitro and may play the same role in the ferroptosis inhibition in human cells at level below our detection limit, we cannot rule out the possibility that 6-hydroxy-FAD may not be stably stored in human cells and the feeding 6-hydroxy-FAD blocks ferroptosis probably by other unclear mechanism

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