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 duodenoscopes. With the clearance, the Philadelphia-based company’s line of System 83 Plus AERs are cleared for washing and disinfecting the Olympus (TYO:7733) TJF-180V and Pentax ED-3490TK duodenoscopes, according to an FDA […]
Sterilization / Calibration
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 device and reduce oxygen supply requirements. The company’s Sterizone VP4 is a low-temperature sterilization system which uses dual-sterilants of vaporized hydrogen peroxide and ozone for […]
Medizone to launch further AscepticSure testing in pursuit of FDA de novo pathway
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 pursuit will require further data collection on the device. The AsepticSure system is designed to be turned on from outside the room to be disinfected, enabling the machine […]
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 Stanford Byers Center for Biodesign in 2012, said its CleanCision device is the 1st in a new category of irrigating wound protection devices, as classified by […]
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 U.S. Securities and Exchange Commission filing. The company has raised $4,827,500 toward its present $12 million goal, according to a Form D filed with […]
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. 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 heat and […]
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 drew its inspiration from the name of the Greek goddess of safety, Soteria, and is meant to reflect the company’s commitment to global health. […]
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 $4.90-per-share offering, of 1.2 million shares of common stock with warrants to purchase an additional 918,366 shares, grossed $6 million, delivering $5.1 million in net proceeds. Those […]
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 the room to be disinfected, enabling the machine to safely fill the room with a disinfecting gas formula. The device later clears the atmosphere […]
UVC LEDs: Energizing a new generation of portable, healthcare disinfection devices
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 hospital-acquired infection (HAI) during their visit. Often expensive and sometimes fatal, HAIs are adding billions to the country’s already bourgeoning healthcare costs. For decades, hospitals and other healthcare facilities […]
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 feasibility and research studies for pharma, biotech and med device firms. Baltimore, Md.-based Noxilizer said it expects to have the 1st NO2 sterilization systems operational at Sterigenics facilities […]