FDA clears DxNow ’ s sperm separation device

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 k...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance dxnow Source Type: news

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Authors: Zarandi NP, Galdon G, Kogan S, Atala A, Sadri-Ardekani H Abstract While the survival rate of children with cancer is increasing, preserving fertility for prepubertal boys is still a challenge. Although intracytoplasmic sperm injection (ICSI) using frozen sperms has revolutionized infertility treatment, it is not applicable for the patients who undergo chemotherapy before puberty since spermatogenesis has not begun. Therefore, preserving spermatogonial stem cells (SSCs) as an experimental option can be provided to prepubertal patients at a risk of damage or loss of their SSCs due to cancer treatments and de...
Source: Stem Cells and Cloning: Advances and Applications - Category: Stem Cells Tags: Stem Cells Cloning Source Type: research
Publication date: May 2018Source: Reproductive BioMedicine Online, Volume 37, Supplement 1Author(s): Andrea Abdala, Laura Vargas, Ernesto Gómez Passanante, Sergio Provenzano, Javier Singla
Source: Reproductive BioMedicine Online - Category: Reproduction Medicine Source Type: research
Conclusion(s)Pregnancy/retrieval and ongoing pregnancy rates are comparable among the three protocols with GnRH agonist stop protocol having non-significantly higher rates.
Source: Middle East Fertility Society Journal - Category: Reproduction Medicine Source Type: research
ConclusionFinal oocyte maturation with dual trigger improves the number of good quality embryos in normal responder women. Further research with larger sample size is needed to characterize the effect on oocyte quality and pregnancy rate.
Source: Middle East Fertility Society Journal - Category: Reproduction Medicine Source Type: research
Publication date: Available online 14 June 2018Source: Middle East Fertility Society JournalAuthor(s): Wardah Alasmari, Fawaz Edris, Zainab Albar, Mamdoh Eskandar, Camellia Sultan, Amer Alboush, Abdulaziz AlasmariAbstractObjectiveThe aim of this study was to compare intra-Cytoplasmic Sperm Injection (ICSI) outcomes (fertilization rate, embryo quality, pregnancy rate, and live birth rate) for couples with unexplained infertility and couples with male factor infertility, and if the quality of semen is related to ICSI outcomes.MethodsThis is a retrospective chart review of 2038 ICSI cycles performed between 2008 and 2014 to c...
Source: Middle East Fertility Society Journal - Category: Reproduction Medicine Source Type: research
ConclusionCalcium infusion is more effective than oral cabergoline intake from OPU day in the reduction of OHSS overall incidence as well as its severity with comparable pregnancy outcomes.Trial registration: https://clinicaltrials.gov/ct2/show/NCT03473613.
Source: Middle East Fertility Society Journal - Category: Reproduction Medicine Source Type: research
ConclusionsAspiration of ECF at the time of egg collection is another new option for women with ECF. It obviated the need to freeze all or aspirate of ECF at the time of ET. It was associated with a good success andcan be a new convenient option in couples residing in low income countries. More studies are needed to establish the best management of ECF.
Source: Middle East Fertility Society Journal - Category: Reproduction Medicine Source Type: research
AbstractPurposeTo investigate the effect of sperm concentration, motility and advanced paternal age on reproductive outcomes.MethodsA retrospective analysis of 1266 intracytoplasmic sperm injection (ICSI) cycles between 2013 and 2017. The cohort was divided into four groups according to semen concentration based on the WHO criteria (2010): group A (conc.
Source: Journal of Assisted Reproduction and Genetics - Category: Reproduction Medicine Source Type: research
ConclusionThe significant role of SDF in male factor infertility is supported by current evidence. The beneficial role of SDF testing in selection of varicocelectomy candidates, evaluation of patients with unexplained infertility and recurrent pregnancy loss, selection of the most appropriate assisted reproductive technique with highest success rate for infertile couples, and assessment of infertile men with modifiable lifestyle factors or gonadotoxin exposure has been recently proposed.
Source: Arab Journal of Urology - Category: Urology & Nephrology Source Type: research
ConclusionVaricocele repair is a cost-effective treatment method that can improve semen parameters, pregnancy rates, and live-birth rates in most infertile men with clinical varicocele. By improving semen parameters and sperm structure, varicocele repair can decrease or even eliminate ART requirement.
Source: Arab Journal of Urology - Category: Urology & Nephrology Source Type: research
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