Unisense FertiliTech A/S Receives CE Mark of Approval for EmbryoScope(TM) Embryo Monitoring System

Saturday, September 19, 2009 General News J E 4
AARUHS, Denmark, July 6 Unisense FertiliTech A/S( announces that the EmbryoScope(TM) EmbryoMonitoring System and EmbryoSlide(TM) tray have received CE approval as classIIa medical devices for use in IVF. Unisense Fertilitech A/S also receivedthe DS/EN ISO13485:2003 and AC:2007 quality system certificate forproduction, installation and servicing of IVF incubators and relatedaccessories.

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Francesca Bahr, sales manager at Unisense FertiliTech A/S says, "the CEmark will allow us to market the instrument to Assisted Reproduction clinicsacross Europe, with the goal of improving embryo assessment and to facilitatethe goal of elective single embryo transfer."

During IVF treatment, multiple oocytes are removed from the patient andfertilized in-vitro. The resulting fertilized eggs are cultured for a periodof 2 to 5 days, before the embryologist must select the best potential embryoor embryos to transfer to the patient. Ideally, a single embryo resulting ina single pregnancy is optimal as multiple pregnancies present risks tomaternal and fetal health.

A major challenge for the embryologist is determining which embryos havethe best potential to create a single healthy baby.

The EmbryoScope(TM) Monitoring System allows uninterrupted observation ofembryo development in a stable environment. Embryo quality parameters can beassessed and reviewed without the potentially damaging effects of removingthe embryo from a controlled incubation environment. Retrospective analysisof development will allow embryologists to identify potentially newparameters for embryo analysis.

Mette Munch, Director of regulatory affairs at Unisense FertiliTech A/Ssays she will now set her goal on FDA 510K clearance in order to facilitatemarketing to clinics in the United States.

The Announcement of the CE mark coincided with the successful saleslaunch of the EmbryoScope(TM) Embryo Monitoring System at the Europeansociety of Human reproduction and Embryology in Amsterdam, June 29.July 1 2009

Unisense Fertilitech A/S is a Danish company which was founded in 2003,as a daughter company of Unisense A/S. The company develops and manufacturesinstruments and analysis solutions to facilitate in-vitro Fertilization. Thecompany is currently involved in various international research projectsinvolving embryo selection and analysis, embryo respiration and stem cellresearch.


SOURCE Unisense FertiliTech A/S


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