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Unisense FertiliTech A/S's EmbryoScope(R) Receives FDA 510(k) Clearance for 5 Day Culture of Human Embryos in IVF


10/13/2011 7:06:12 AM

Unisense FertiliTech's EmbryoScope® Receives FDA 510(k) Clearance for 5 Day Culture of Human Embryos in IVF

PR Newswire

AARHUS, Denmark, October 13, 2011 /PRNewswire/ --

The Food and Drug Administration has cleared Unisense FertiliTech's EmbryoScope® for clinical use in the United States. The EmbryoScope® is a tri-gas IVF incubator with a built-in camera for automated time-lapse imaging of fertilized oocytes in a safe incubation environment from conception until the time of transfer. Embryo development may be continuously observed on the instrument interface without disturbances to embryo culture for up to 5 days.

(Photo: http://www.newscom.com/cgi-bin/prnh/20111013/486941 )

Separate processing units control the incubation environment and the data acquisition to ensure safe and reliable operation. The EmbryoScope® allows incubation of up to 72 individual embryos in six sterile disposable EmbryoSlides® each with a capacity for 12 embryos.

CEO Jens Gundersen states "the clearance will allow the newly established USA office, FertiliTech Inc. to commence commercial activities in the US".

Unisense FertiliTech A/S was founded in 2003 as a subsidiary of Unisense A/S. The company develops and sells technology and software for improvement of assisted reproduction. The company has 34 employees and a domicile in Aarhus Denmark.

http://www.fertilitech.com

SOURCE Unisense FertiliTech A/S


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