Medical device company STERIS (NYSE:STE) has received long-awaited U.S. Food and Drug Administration clearance on an accessory part for its System 1E liquid chemical sterilization device. The newly cleared product, the Verify Spore Test Strip, is an optional part that’s used to monitor the sterility of a chemical cleaning agent used in the system. The System 1E is used by hospitals, surgical centers and other healthcare facilities to sterilize heat-sensitive medical instruments. Clearance of the accessory part was done through the FDA’s de novo process, which is generally used for devices that aren’t high risk, but don’t have a “substantially equivalent” counterpart on the market, according to an U.S. Securities and Exchange filing by Mentor, Ohio-based STERIS.
