Unisense FertiliTech A/S Receives CE Mark of Approval for EmbryoScope(TM)
Embryo Monitoring System
AARUHS, Denmark, July 6 /PRNewswire/ -- Unisense FertiliTech A/S
(http://www.fertilitech.com) 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.
(Photo: http://www.newscom.com/cgi-bin/prnh/20090706/353010 )
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.
Website: http://www.fertilitech.com
SOURCE Unisense FertiliTech A/S
Contact Person: Francesca Bahr, Sales and Marketing Manager, Unisense
FertiliTech A/S, Phone Number, +45-89449525, Mobile Phone: +45-40255538, Email
Address, fab@fertilitech.com
