The European Union requires companies to comply with the Medical Devices Directive in order to sell medical devices in its 27 member countries; the CE mark is evidence that ClearCount and its product offerings meet the requirements of these directives.
The SmartSponge product line is the first and only RFID-based surgical safety and efficiency technology bearing a CE mark, according to the release. The SmartSponge System identifies each sponge in an operating room so they can be both counted and detected during surgery.
“We have established a perfect safety record over the past two years in the United States. Our hospital customers have never experienced a retained surgical sponge while using our technology,” said David Palmer, chief executive officer of ClearCount, in the release. “CE mark approval of our SmartSponge System and SmartWand-DTX represents a significant achievement and major milestone for our company.”
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