Cytori Therapeutics received US 510(K) regulatory clearance from the FDA’s Center for Devices and Radiological Health for its adipose (fat) tissue processing system with a related Celase™ tissue processing reagent.
“This is a critical addition to Cytori’s compilation of US regulatory clearances toward a fully automated adipose tissue processing system,” says Christopher J. Calhoun, Cytori CEO. “Cytori will submit additional regulatory filings this year to enable US introduction of the optimal commercial system.”
The system is intended for use in plastic and reconstructive, thoracic, gastrointestinal, urological, and orthopedic surgeries, when processing fat or soft tissue is required.
[home.businesswire.com, January 25, 2007]