Pittsburgh-based ClearCount Medical Solutions has announced FDA 510(k) clearance for its SmartWand-DTX system, according to a ClearCount news release.
The SmartWand-DTX is a patient safety tool that augments manual sponge counts while providing positive identification and detection of retained surgical sponges. The system is complementary to ClearCount's SmartSponge System, which uses RFID technology.
The SmartWand-DTX system will allow a surgeon to scan the patient before closing to identify and locate unintentionally retained surgical sponges.
"This clearance to market is a significant milestone for our customers, employees and investors," David Palmer, CEO of ClearCount, said in the release. "We are commercializing a detection system that offers broad advantages over current offerings. SmatWand-DTX, in addition to our award-winning SmartSponge System, for the first time provides hospitals a choice of devices to best address the unique conditions of each OR."
ClearCount Medical Solutions is the only provider of RFID-bases systems for the prevention of retained surgical sponges, according to the release.
Read the ClearCount release on SmartWand-DTX.