Cytori's Celution® 700 System to be Regulated as a Medical Device by U.S. FDA
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Cytori's Celution® 700 System to be Regulated as a Medical Device by U.S. FDA
Press Release
Source: Cytori Therapeutics
On Friday July 17, 2009, 7:00 am EDT
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Companies: Cytori therapeutics, inc.
SAN DIEGO--(BUSINESS WIRE)--Cytori Therapeutics (NASDAQ:CYTX - News) was informed by the U.S. Food and Drug Administration (FDA) that the Celution® 700 System will be regulated as a medical device under the Federal Food, Drug, and Cosmetic Act. This determination, in response to Cytori’s Request for Designation, clears the way for Cytori to compile and submit a marketing application to the FDA for the Celution® 700 System for use as a medical device in aesthetic body contouring and/or filling of soft tissue voids.
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“This important decision provides greater clarity of our regulatory path in the U.S. and is consistent with our interpretation of current device regulations,” said Christopher J. Calhoun, chief executive officer for Cytori. “We are preparing for the next steps in the process of working with the FDA to determine the specific device marketing application to submit, including whether clinical evaluations will be necessary.”
Based on the jurisdictional determination from the FDA, marketing applications for the Celution® 700 device will be reviewed by the FDA’s Center for Biologics Evaluation and Research under the law applicable to medical devices. Clinical investigations, if required, would be conducted in accordance with the Investigational Device Exemption (IDE) regulations, not the Investigational New Drug regulations applicable to drugs and biologics.
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