In a Feb. 22 letter, the U.S. Food and Drug Administration warned makers of endoscopes to change their labeling as soon as possible if they recommend using STERIS Corp.’s System 1 to sterilize their devices after use.
[Read more of this report]US Endoscopy has launched another product — a portable colon irrigation system called Velocity.
[Read more of this report]US Endoscopy has introduced the Talon grasping device to help doctors extract food and other objects from patients’ digestive tracts and airways. The Talon device, which is used with an endoscope, was designed to mimic the grasping abilities of an osprey.
[Read more of this report]STERIS Corp. reported higher operating profits and a modest increase in revenue for its fiscal third quarter over the year-ago quarter. However, the maker of infection protection, decontamination and life science technologies said its future profits are unclear because it has been unable to resolve problems the FDA has with its System 1 sterilizer.
[Read more of this report]The U.S. Food and Drug Administration has posted a notice on alternatives to System 1, the medical instrument sterilizer made by STERIS Corp. in Mentor, Ohio, that the administration considers a “violating device.”
[Read more of this report]STERIS Corp. seems to have turned a corner in its disagreement with the U.S. Food and Drug Administration about what customers should do with 23,000 System 1 sterilization units worldwide. The latest STERIS response to the FDA’s challenge of its System 1 lacked any mention of disagreement, unlike other responses the company has made to the regulator since it targeted the device in a May 2008 warning letter.
[Read more of this report]Shares of STERIS Corp. rebounded slightly today from a 12 percent hit on Friday following a U.S. Food and Drug Administration safety alert for the company’s System 1 sterilizer. STERIS shares rose $1.06, or 3.6 percent, to $30.20 on the New York Stock Exchange.
[Read more of this report]STERIS Corp. and NeoForce Group Inc. have agreed to jointly market the world’s first surgical system designed just for newborn babies.
[Read more of this report]The U.S. Food and Drug Administration has issued a safety alert for a sterilization device from Steris Corp., warning that the device has the potential to cause “serious injuries,” such as infections to patients.
[Read more of this report]STERIS Corp. will pay shareholders a $2-per-share special dividend in December and likely will be more profitable than expected in fiscal 2010, largely as a result of past cost cutting, and fortuitous trends in foreign currency rates and raw materials costs. Because of its strong cash position, STERIS director approved a special $2-a-share dividend, which will return $120 million to shareholders.
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