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:11/25/2015)... , November 26, 2015 ... Global Biobanking Market 2016 - 2020 report analyzes ... maintaining integrity and quality in long-term samples, minimizing ... long-term cost-effectiveness. Automation minimizes manual errors such as ... technical efficiency. Further, it plays a vital role ...
(Date:11/25/2015)... BRUSSELS , November 25, 2015 ... in cat and human plaque and pave the way for ... health problems in cats     ... the most commonly diagnosed health problems in cats, yet relatively ... until now. Two collaborative studies have been conducted by researchers ...
(Date:11/25/2015)... 2015 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ:  AEZS; TSX: ... prospects remain fundamentally strong and highlights the following ... received DSMB recommendation to continue the ZoptEC Phase ... the final interim efficacy and safety data ... men with heavily pretreated castration- and Taxane-resistant prostate ...
(Date:11/25/2015)... November 25, 2015 The ... is a professional and in-depth study on the ...      (Logo: ) , ... industry including definitions, classifications, applications and industry chain ... the international markets including development trends, competitive landscape ...
Breaking Biology Technology:
(Date:11/11/2015)... MINNETONKA, Minn. , Nov. 11, 2015   MedNet ... the entire spectrum of clinical research, is pleased to announce ... Partnerships in Clinical Trials (PCT) event, to be held ... will be able to view live demonstrations of ... platform, and learn how iMedNet has been able ...
(Date:11/9/2015)... 09, 2015 ... the "Global Law Enforcement Biometrics Market ... --> ) has announced the ... Biometrics Market 2015-2019" report to their ... ( ) has announced the addition ...
(Date:11/2/2015)... 2, 2015  SRI International has been awarded a ... development services to the National Cancer Institute (NCI) PREVENT ... scientific expertise, modern testing and support facilities, and analytical ... and toxicology studies to evaluate potential cancer prevention drugs. ... PREVENT Cancer Drug Development Program is an NCI-supported pipeline ...
Breaking Biology News(10 mins):