Infection prevention products manufacturer Tristel is seeking regulatory approval for its Tristel ULT hand-applied high-level disinfectant foam as a Class II medical device for endocavity ultrasound probes and skin surface transducers.
The company has submitted the Tristel ULT application to Health Canada and expects a decision early next year.
The Tristel ULT foam for medical devices received US Food and Drug Administration (FDA) approval in June 2023 for use on endocavity ultrasound probes and skin surface transducers.
Tristel CEO Paul Swinney said: “When we received our FDA approval for Tristel ULT in June, we set out for our shareholders our commercial strategy for North America. This included the submission to the Canadian regulatory authority of Tristel ULT during the current financial year and its approval before the end of H1 FY2025.
“I am pleased to report that we have accelerated our plans and can look forward to a commercial launch into the Canadian ultrasound market during our second half.”
Parker Laboratories, Tristel’s North American business partner, will be responsible for manufacturing Tristel ULT.
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The Tristel ULT is planned to be distributed through Parker’s distributor network to ultrasound users in Canada.
Swinney added: “Parker Laboratories is well advanced in preparing to manufacture the Tristel foam disinfectants and we are on target to launch into the United States ultrasound market on or before 1 October 2023.”
Health Canada has already approved Tristel OPH, a high-level disinfectant for ophthalmic instruments, as a Class II Medical Device in 2021.