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

Main Category: Fertility
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 07 Jul 2009 - 1:00 PDT

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Unisense FertiliTech A/S announces that the EmbryoScope(TM) Embryo Monitoring System and EmbryoSlide(TM) tray have received CE approval as class IIa medical devices for use in IVF. Unisense Fertilitech A/S also received the DS/EN ISO13485:2003 and AC:2007 quality system certificate for production, installation and servicing of IVF incubators and related accessories.

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

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

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

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

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

The Announcement of the CE mark coincided with the successful sales launch of the EmbryoScope(TM) Embryo Monitoring System at the European society 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 manufactures instruments and analysis solutions to facilitate in-vitro Fertilization. The company is currently involved in various international research projects involving embryo selection and analysis, embryo respiration and stem cell research.

Source: Unisense FertiliTech A/S