Macropore FDA Zulassung (mt) - 500 Beiträge pro Seite
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Press Release Source: MacroPore Biosurgery, Inc.
MacroPore Biosurgery Receives 510/k Clearance for Adipose Tissue Extraction System
Friday September 24, 2:00 am ET
SAN DIEGO--(BUSINESS WIRE)--Sept. 24, 2004--MacroPore Biosurgery, Inc. (Frankfurt:XMP) announced today that it has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a point-of-care adipose tissue extraction system, which is designed to extract and collect adipose tissue.
"We are pleased to have received our first clearance related to our regenerative cell technology platform," said Marc H. Hedrick, M.D., President of MacroPore Biosurgery. "This clearance, which represents an important step in our development process, is one of multiple components of the system that will require clearance or approval by the FDA prior to commercialization."
The claims for the adipose tissue extraction system specifically cover the fragmentation, emulsification, and aspiration of soft tissue, such as adipose tissue, for multiple surgical specialties including thoracic surgery, orthopedic surgery and plastic and reconstructive surgery.
MacroPore Biosurgery and its collaborators have shown that adipose tissue is a rich source of autologous regenerative cells. MacroPore Biosurgery is currently conducting pre-clinical studies at several highly regarded academic institutions around the world to study the role of adipose-derived regenerative cells.
MacroPore Biosurgery Receives 510/k Clearance for Adipose Tissue Extraction System
Friday September 24, 2:00 am ET
SAN DIEGO--(BUSINESS WIRE)--Sept. 24, 2004--MacroPore Biosurgery, Inc. (Frankfurt:XMP) announced today that it has received a 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a point-of-care adipose tissue extraction system, which is designed to extract and collect adipose tissue.
"We are pleased to have received our first clearance related to our regenerative cell technology platform," said Marc H. Hedrick, M.D., President of MacroPore Biosurgery. "This clearance, which represents an important step in our development process, is one of multiple components of the system that will require clearance or approval by the FDA prior to commercialization."
The claims for the adipose tissue extraction system specifically cover the fragmentation, emulsification, and aspiration of soft tissue, such as adipose tissue, for multiple surgical specialties including thoracic surgery, orthopedic surgery and plastic and reconstructive surgery.
MacroPore Biosurgery and its collaborators have shown that adipose tissue is a rich source of autologous regenerative cells. MacroPore Biosurgery is currently conducting pre-clinical studies at several highly regarded academic institutions around the world to study the role of adipose-derived regenerative cells.
Sorry bin noch nicht ganz wach noch keine FDA Zullasung,laut Text, währe der nächste Schritt!
schnulli wie immer
na, der traue ich immer n icht so recht
rofl
minus 4%
wie immer
pusher adhoc und fett abverkauf
lol
minus 4%
wie immer
pusher adhoc und fett abverkauf
lol
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