ClearCount Medical Solutions Announces 510(K) Clearance Of Its SmartWand-DTX
ClearCount Medical Solutions, an innovator of patient safety solutions for the operating room, recently announced 510(k) clearance from the United States Food and Drug Administration (FDA) to begin commercialization of its lower cost SmartWand-DTX™ system. The SmartWand-DTX provides hospitals and surgery centers with a new patient safety tool that simply and easily augments their manual sponge counts while also providing positive identification and detection of retained surgical sponges. This complementary offering to ClearCount's award-winning SmartSponge® System provides an economical and flexible approach to implementing the latest RFID technology.
By virtue of its ability to both count and detect, the system can be used to validate manual counting of all tagged sponges before, during, and after surgery. Further, the surgeon is able to scan the patient before closing to identify and locate unintentionally retained surgical sponges. The SmartWand-DTX is easy-to-use and provides more information than other detection systems. The system is not only compact and portable, it also allows for less waste than other options because it is reusable.
"This clearance to market is a significant milestone for our customers, employees and investors," said David Palmer, Chief Executive Officer of ClearCount. "We are commercializing a detection system that offers broad advantages over current offerings. SmartWand-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 O.R."
The Centers for Medicare and Medicaid Services (CMS) mandated as of October 2008 they would no longer reimburse for procedures associated with "never" events such as left-behind surgical sponges. Many private insurers are following suit. Published studies today indicate that one in every 1,000 to 1,500 intra-abdominal surgeries results in a sponge left behind in a patient. A retained sponge incident can lead to serious complications, including sepsis, unnecessary X-rays, need for repeat surgeries and even death.
ClearCount Medical Solutions is the only provider of RFID-based systems for the prevention of retained surgical sponges. The ClearCount SmartSponge System, for count reconciliation and detection of surgical sponges, has received multiple awards including Popular Science's Best of What's New in 2009. Both products are now available through Medline Industries, Inc., the nation's largest privately held manufacturer and distributor of healthcare supplies.
About ClearCount Medical Solutions
ClearCount Medical Solutions is a medical device company focused on patient safety solutions. ClearCount has assembled an extendable RFID-based platform that provides a comprehensive solution to improve efficiency while preventing medical errors. ClearCount Medical Solutions has been recognized with a Popular Science 2009 Best of What's New Award, and has received additional recognition from TIME and WIRED magazines, the 2009 Wall Street Journal Technology Innovation Award, the International Design Excellence Award (IDEA) and more. ClearCount's SmartSponge and SmartWand-DTX systems are the only RFID enabled systems for counting and detecting surgical sponges, thereby improving patient and OR safety, enhancing productivity, and reducing cost. For more information, visit www.clearcount.com.
SOURCE: ClearCount Medical Solutions