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

AARUHS, Denmark, July 6 /PRNewswire/ -- 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.

(Photo: )

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
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. WuXi PharmaTech Receives Award from BASF
2. AEterna Zentaris Receives US$10 Million from Institutional Investors
3. SyntheMed Receives Frost & Sullivan Health Innovation Award Nomination
4. CutisPharma, Inc. Receives Verified Accreditation for Wholesale Distributors from the National Association of Boards of Pharmacy for Woburn Facility
5. Sinovac Receives Chinas First Influenza A (H1N1) Vaccine Order
6. Hospira Receives Favorable Court Decision on Eloxatin(R)
7. Berlin Heart Inc. Receives FDA Orphan Product Development Grant
8. MicroFluidic Systems (MFSI) Receives Patent for Method to Selectively Process Different Biological Cell Types for Analysis.
9. PTC Therapeutics Receives $2.6 Million in Government Grants
10. Delcath Systems Receives Preliminary Notification of Inclusion in Russell 3000(R) Index
11. Hill-Rom Innovative Envision(R) E700 Wound Surface Receives Gold Medical Device Excellence Award
Post Your Comments:
(Date:11/26/2015)... CHESHAM , England , November 26, ... Lightpoint Medical, an innovative medical device company specializing in ... Euro grant from the European Commission as part of the ... enabling the company to carry out a large-scale clinical trial ... -->      (Logo: , ...
(Date:11/25/2015)... -- PharmAthene, Inc. (NYSE MKT: PIP) announced  today that its ... (Rights Plan) in an effort to preserve the value ... 382 of the Internal Revenue Code (Code). ... its NOLs could be substantially limited if the Company ... of the Code. In general, an ownership change occurs ...
(Date:11/25/2015)... Studies reveal the differences in species of ... way for more effective treatment for one of the most ... --> --> Gum disease is ... yet relatively little was understood about the bacteria associated with ... by researchers from the WALTHAM Centre for Pet Nutrition together ...
(Date:11/25/2015)... 2015  Neurocrine Biosciences, Inc. (Nasdaq: NBIX ) ... CEO of Neurocrine Biosciences, will be presenting at the ... New York . .   ... 5 minutes prior to the presentation to download or ... will be available on the website approximately one hour ...
Breaking Biology Technology:
(Date:11/12/2015)... 12, 2015  A golden retriever that stayed healthy ... (DMD) has provided a new lead for treating this ... Broad Institute of MIT and Harvard and the University ... Cell, pinpoints a protective gene ... disease,s effects. The Boston Children,s lab of Lou ...
(Date:11/11/2015)... MedNet Solutions , an innovative SaaS-based eClinical technology company that ... announce that it will be a Sponsor of the ... held November 17-19 in Hamburg , Germany.  ... iMedNet , MedNet,s easy-to-use, proven and affordable eClinical ... able to deliver time and cost savings of up to ...
(Date:11/9/2015)... DUBLIN , Nov. 09, 2015 /PRNewswire/ ... announced the addition of the "Global ... to their offering. --> ... "Global Law Enforcement Biometrics Market 2015-2019" ... Research and Markets ( ) ...
Breaking Biology News(10 mins):