• Nephros (River Edge, New Jersey) said it has received initial responses from the FDA's review of the company's 510(k) submissions for dialysis devices. Nephros submitted a 510k application to the FDA for approval to market its leading-edge hemodiafiltration products for end-stage renal disease in the U.S. Nephros's OLpur MD220 filter is designed expressly for HDF therapy that employs Nephros's proprietary Mid-Dilution Diafiltration technology. Nephros's OLpur H2H Hemodiafiltration module enables existing dialysis machines to be used for HDF therapy. The Nephros HDF system removes a range of harmful substances more effectively, and with greater capacity, than existing ESRD treatment methods, particularly with respect to substances known collectively as "middle molecules."

• Quick-Med Technologies (Gainesville, Florida) said it has received FDA clearance for its Nimbus barrier gauze wound care dressings. The company says that what makes Nimbus-treated gauze different from other antimicrobial dressings are its permanent bond and its ability to be effective even in the presence of large amounts of serum and exudate. The active agent is permanently bonded to the gauze, keeping the biocide from depletion, while killing microbes (such as MRSA, VRE, and many others) that are drawn into the absorbent dressing. Nimbus is non-toxic, long-lasting and not blocked by organics such as blood, urine and perspiration. Product labeling has been allowed that indicates various organisms such as MRSA, VRE, Pseudomonas aeruginosa and Escherichia coli are killed at levels exceeding 99.999%.

• RF Code (Austin, Texas) has introduced a dry contact tag that provides the freedom to monitor dry contact devices without the deployment and cost limitations of traditional wired solutions. Dry contact devices have terminals that are normally either "closed" or "open" to indicate that a condition is normal for example, that a chiller's Freon is at acceptable levels. When something happens to affect that, such a drop in the Freon level, the dry contact terminals either close or open, depending on which is the abnormal state for that device. The R130 Dry Contact Tag has two twisted wires to enable connection to a dry contact device. Once connected, the R130 will monitor and report the open and closed states of the device. While the connected device is in either an open or closed state the tag will beacon the dry contact status once every 10 seconds. When the dry contact state changes the tag will immediately broadcast three beacons at 0.5 seconds apart with the new dry contact status then return to beaconing once every 10 seconds. The tag enclosure snaps together, allowing for battery replacement when a low-battery condition is detected.

No Comments