Medical Device

TSO3 announced its targeting a 510(k) clearance for their STERIZONE VP4 Sterilizer from US regulators.

TSO3 (TSX:TOS) announced its targeting a 510(k) clearance for their STERIZONE VP4 Sterilizer from US regulators.
As quoted in the press release:

Plans are to launch regulatory filings with US regulators for both the Olympus TJF-Q180V and Pentax ED-3490TK duodenoscopes within weeks of each other beginning in July 2017.  The Company’s goal is to receive US clearance by the end of 2017.  Clearances already exist in Europe and Canada for the terminal sterilization of both of the duodenoscopes.
TSO3‘s STERIZONE® VP4 sterilizer is already validated and cleared in the US, Europe and Canada to terminally sterilize multi-channel flexible endoscopes, such as video colonoscopes and gastroscopes, of up to 3.5 meters in length and with four or fewer channels.
“We are pleased to move forward and expand our duodenoscope regulatory strategy.  Filing for US duodenoscope clearance is a natural and further step in our quest to help healthcare facilities improve their standard of care by providing sterile duodenoscopes and other endoscopes to their patients,” stated R.M.(Ric) Rumble TSO3‘s President and CEO. “US regulatory clearance of duodenoscopes, along with our other healthcare-leading flexible endoscope claims, would help address industry concerns over the safety and effectiveness of less robust high-level disinfection systems.”

Click here to read the full press release.

Source: www.newswire.ca

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