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Medical Devices / Submissions and Approvals

DxNow Cleared for ZyMot Sperm Separation Devices

April 4, 2018
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The FDA granted 510(k) clearance for DxNow’s ZyMot ICSI and ZyMot Multi, devices intended for preparing motile sperm from semen to be used in infertile couples.

The devices facilitate the separation and preparation of highly-motile sperm with normal morphology to be used in assisted reproductive technology procedures.

The ZyMot devices can be used to prepare sperm for intracytoplasmic sperm injection, intrauterine insemination and in vitro fertilization procedures.

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