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DxNow received FDA 510(k) clearance in March 2018[3] for its ZyMōt ICSI and ZyMōt Multi sperm separation devices. The devices are designed to simulate the cervical and uterine pathway, facilitating separation and preparation of highly-motile sperm with normal morphology for use in assisted reproductive technology (ART) procedures including intracytoplasmic sperm injection (ICSI), intrauterine insemination (IUI), and in vitro fertilization (IVF)[4]. The ZyMōt devices were the first of their kind cleared in the U.S. market[3].
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