TSO3 receives FDA's clearance for expanded use
Multi-channel flexible endoscopes now indicated for use
TSO3 Inc. ("TSO3") (TSX: TOS.TO), an innovator in low temperature sterilization technology for medical devices in healthcare settings through the use of ozone, today announced that the Company has received clearance from the US Food and Drug Administration to expand the intended use claims for its TSO3 STERIZONE(R) 125L Sterilizer. These new claims include the sterilization of packaged, multi-channel flexible endoscopes, such as colonoscopes, gastroscopes, bronchoscopes, ureteroscopes and choledochoscopes.
"During the past nine months, we have maintained an ongoing exchange of information with the US regulatory agency concerning our procedures and documentation supporting these expanded claims", stated R.M. (Ric) Rumble TSO3's President and CEO. "Today's clearance is important for the Company in two ways: First we have demonstrated that our systems are robust and we can pass the rigorous standards of the US agency in a timely manner.
- Published: 04 December 2009
- Written by Editor