Medizone said last week it will pursue de novo clearance for its AsepticSure disinfection system after speaking with the FDA about its 513(g) submission. The AsepticSure system is designed to be turned on from outside the room to be disinfected, enabling the machine to safely fill the room with a disinfecting gas formula. The device […]
Sterilization / Calibration
TSO3 rebounds after short-seller’s report triggers plunge
Share prices for TSO3 (TSE:TOS) rebounded somewhat today after taking a beating yesterday on a short-seller’s report questioning the company’s stability. The short seller, Spruce Point Mgmt., accused the Canadian company of not disclosing the installed customer base for its Sterizone VP4 sterilizer as promised this year because, “if it did, investors might see just […]
TSO3 files FDA app seeking duodenoscope indication for Sterizone VP4 sterilizer
TSO3 said today it filed a 510(k) application with the FDA as it seeks to clear its Sterizone VP4 sterilizer for the terminal sterilization of duodenoscopes used in endoscopic retrograde cholangio-pancreatography procedures. The company’s Sterizone VP4 is a low-temperature sterilization system which uses dual-sterilants of vaporized hydrogen peroxide and ozone for the terminal sterilization of […]
NanoVibronix touts bacterial reduction in interim UroShield study results
NanoVibronix (NSDQ:NVBXU) today released interim trial results from a study of its UroShield ultrasound device designed to prevent bacteria and biofilms from forming on urinary catheters, touting significant reductions in bacterial numbers. The study, which currently has 22 patients, compared patients treated with placebo devices to those with the UroShield. Upon initiation, each patient in the […]
FDA clears Custom Ultrasonics to resume manufacturing System 83 endoscope washer-disinfector
Custom Ultrasonics said yesterday that the FDA inspected and cleared its manufacturing facility in Ivyland, Penn, reinstating the manufacturing, packing and distribution of the company’s System 83 Plus washer and disinfector for use with non-duodenoscope endoscopes. The Philadelphia-based company said that it was required to perform independent validation testing for its System 83 Plus water filtration […]
Stryker picks up controlled substance disposal device maker Cactus
Stryker (NYSE:SYK) said yesterday it acquired all of the assets of controlled substance waste management system maker Cactus, LLC. Cactus produces the Smart Sink, Pharma Lock and Pharma Lock O.R. controlled substance waste management systems designed to render waste which could contain controlled substances unrecoverable and unusable. The Smart Sink system is designed to capture […]
Medizone to pursue FDA 510(k) for AsepticSure
Medizone said last Friday after meeting with the FDA that it will pursue 510(k) clearance for its AsepticSure portable hospital disinfection system. The system is designed to be turned on from outside the room to be disinfected, enabling the machine to safely fill the room with a disinfecting gas formula. The device later clears the […]
BD launches surgical infection control and prevention program
Becton Dickinson & Co. (NYSE:BDX) said today it is launching the Power in Prevention program which aims to reduce risks of infection during surgical procedures. The Power in Prevention program will use a quantitative process to identify potential risks for infections and provide evidence-based infection control strategies for specific areas of quality improvement in skin prep, […]
U.S. CDC labs close over concerns about air hose safety issues
(Reuters) – The U.S. Centers for Disease Control and Prevention has closed down its highest security biosafety laboratories after discovering that hoses that supply air to scientists wearing special protective suits were never approved for that use, the agency said on Friday. “We have no evidence that anybody has suffered ill health effects from breathing […]
Getinge inks distro deal for Ultra Clean Systems’ ultrasonic surgical instrument cleaning equipment
Getinge (PINK:GETI B) said today it inked an exclusive distribution agreement with Ultra Clean Systems to distribute its ultrasonic surgical instrument cleaning systems. Through the deal, Getinge will gain exclusive rights to distribute the full line of Ultra Clean Systems hospital-grade ultrasonic cleaning equipment and accessories and detergent for cleaning Intuitive Surgical’s da Vinci robotic instruments in […]
Vioguard raises $5m in Series A to support ultraviolet disinfection tech
Infection control device company Vioguard said today it raised $5 million in a Series A round of financing, with funds slated to support expanded sales and marketing and accelerated product development. The round for the Bothwell, Wash.-based company was led by Imagen Capital Partners, and brings the total raised for the company to $11 million. […]