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Article: Pharma company receives U.S. FDA clearance for in vitro maturation product.
- Article from:
- Medical Letter on the CDC & FDA
- Article date:
- January 2, 2005
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2005 JAN 2 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration (FDA) has granted MediCult a 510k clearance for its In Vitro Maturation (IVM) product.
The IVM System offered by MediCult (OSE: MEC) is without the use of hormone injections. The system eliminates side effects for the woman and provides a significant reduction in treatment costs of assisted reproduction.
The FDA clearance will allow MediCult to actively market its IVM System in the United States, the world's largest market for infertility treatment.
'Regulatory approval is a key success factor for MediCult's IVM System. In addition, the FDA clearance represents a ...