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Medizone to pursue de novo pathway for AsepticSure disinfection system
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...
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Noxilizer, Sterigenics ink exclusive sterilization deal
Noxilizer and Sterigenics said today they inked a global trade agreement which will position Sterigenics as the exclusive provider of Noxilizer’s nitrogen dioxide contract sterilization services and...
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UVC LEDs: Energizing a new generation of portable, healthcare disinfection...
Mark Pizzuto [Image from Crystal IS]Mark Pizzuto, Crystal IS According to the Centers for Disease Control & Prevention (CDC), one in every 25 hospital patients in the U.S. will contract a...
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Medizone wins CE Mark for AsepticSure
Medizone International (OTC:MZEI) said today that it won CE Mark approval in the European Union for its AsepticSure disinfection system. The AsepticSure system is designed to be turned on from outside...
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NanoVibronix pulls down $5m from public offering
NanoVibronix (NSDQ:NAOV) said today that it pulled down more than $5 million from a public stock offering for its Surface Acoustic Wave antimicrobial platform. The Elmsford, N.Y.-based company said the...
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Sterigenics parent company is now Sotera Health
Sterigenics International said today that it has changed the name of its parent company to Sotera Health, with Nelson Labs, Nordion and Sterigenics as Sotera’s three operating companies. The new name...
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TSO3 responds to FDA info request for Sterizone VP4 duoedenoscope indications
TSO3 (TSE:TOS) said today it responded to a request for additional information from the FDA on its Sterizone VP4 sterilizer as it seeks an indication for the terminal sterilization of duodenoscopes....
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Sterifre Medical raises nearly $5 million for desktop sterilization device
Sterifre Medical, a company that has developed a desktop sterilization device that only uses room temperature plasma, has raised nearly $5 million in its present funding round, according to a recent...
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Prescient Surgical wins FDA nod for CleanCision wound retraction system
Surgical device spin-out Prescient Surgical said today it won FDA clearance for its CleanCision wound retraction and protection system. The San Carlos, Calif.-based company, which was spun out of the...
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Medizone to launch further AscepticSure testing in pursuit of FDA de novo...
Medizone International (OTC:MZEI) said yesterday that following meetings with the FDA, it has decided to pursue de novo clearance with the agency for its AscepticSure disinfection system, and such...
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TSO3 wins expanded FDA nod for Sterizone VP4 sterilizer
TSO3 (TSE:TOS) said late yesterday it won expanded FDA 510(k) clearance for its Sterizone VP4 sterilizer, clearing a new feature of the system that the company claims can improve installation of the...
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FDA OKs limited duodenoscope sterilization by Custom Ultrasonics AERs
The FDA today announced that Custom Ultrasonics completed validation testing of its System Plus automated endoscope reprocessors, and that the devices are cleared for the reprocessing of certain...
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Stryker acquires single-use device reprocessor Hygia Health Services
Stryker (NYSE:SYK) said today it acquired single-use-device reprocessor Hygia Health Services for an undisclosed amount. Birmingham, Ala.-based Hygia has partnered with Kalamazoo, Mich.-based Stryker...
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Fortive offers $2.8B for J&J’s advanced sterilization biz
Johnson & Johnson (NYSE:JNJ) said yesterday that industrial conglomerate Fortive (NTSE:FTV) made a binding offer to acquire the advanced sterilization business from J&J’s Ethicon division for...
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Bronchoscopes still dirty after cleaning, study says
Photo by Michaela33 courtesy of Flikr A new study has found that currently acceptable methods of reprocessing reusable bronchoscopes left most devices contaminated and damaged. “The results are...
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Sterigenics expands in the UK
Sterigenics today announced plans to build a new facility in the Chesterfield/Derbyshire, U.K.’s Markham Vale North area as the company looks to expand its footprint in Europe. The 60,000 square-foot...
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TSO3 drops Getinge, lands $20m debt round for Sterizone VP4
TSO3 (TSE:TOS) said today it is dropping a distribution agreement with Getinge and that it inked a $20 million debt financing deal with a fund under advisement by Courage Capital Management to support...
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Cantel Medical to consolidate Minnesota operations
Cantel Medical (NYSE: CMD) recently purchased an office building in Plymouth, Minn., where it will consolidate four of its locations. The new, four-story, 159,000-square-foot building can accommodate...
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Sterigenics faces lawsuit over ethylene oxide emissions
Sterigenics is facing a lawsuit over alleged emissions of ethylene oxide, a highly carcinogenic chemical compound, according to a press release from law firm Power Rogers & Smith of Chicago. The...
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Illinois EPA seeks temporary shutdown of Sotera Health’s Sterigenics plant
The Illinois Environmental Protection Agency is seeking an order to shut down operations at Sotera Health‘s Sterigenics‘ Willowbrook, Ill.-based facilities that result in the emission of ethylene...
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