Medical device developer DxNow said today it won FDA 510(k) clearance for its ZyMōt ICSI and ZyMōt multi sperm separation devices designed for use in assisted reproductive technology procedures.
The newly cleared devices from the Gaithersburg, Md.-based company are designed for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection, intrauterine insemination and in vitro fertilization procedures.
“We are excited to announce the achievement of this significant milestone in our company’s evolution. This announcement follows CE certification and the introduction of our sperm separation devices in Turkey and several European, Latin American and Asian countries. We have developed devices that make ART procedures faster and less demanding for reproductive medicine professionals. Equally important, we are offering a new pathway for enabling the selection of stronger and healthier sperm, with the ultimate goal of supporting infertile couples striving to conceive,” co-founder & CEO Bill Sharp said in a press release.
DxNow said the devices are the first of their kind to win clearance and approval in the US. The systems are intended to simulate the cervical and uterine patheway to facilitate the separation and preparation of highly-motile sperm with normal morphology for use in ART procedures.
“This is an outstanding validation of our core technology platforms. It is very gratifying to know that our devices are now widely available to serve patients through reproductive medicine professionals in the United States. We will continue to drive ourselves with innovations and to advance the development of these innovations that will help deliver what matters most to infertile couples – facilitating the possibility to conceive,” co-founder, director and scientific advisor Utkan Demirci said in a prepared statement.