TSO3 received a clarification request from US regulators on the company’s submission for extended claims of the STERIZONE VP4 Sterilizer.
TSO3 (TSX:TOS) received a clarification request from US regulators on the company’s submission for extended claims of the STERIZONE VP4 Sterilizer.
As quoted in the press release:
In their correspondence, US regulators requested clarification on certain aspects of the Company’s proposed labeling consistent with the reprocessing of specific duodenoscopes using the STERIZONE VP4 Sterilizer. In addition, acknowledging recent challenges that have impacted ERCP scopes, regulators have also asked for specific testing to be documented pertaining to what they describe as “challenge features” of the identified devices. This includes testing the integrity of the adhesive seal found at and under the distal endcap of the duodenoscope after sterilization processing.
“We are encouraged by the response.” stated R.M. (Ric) Rumble, President and CEO of TSO3. “US regulators have clearly stated that improving the safety of duodenoscopes is a top priority for them, and they are encouraging companies to continue to pursue innovations that will help reduce the risk to patients.