• Non-Invasive Monitoring Systems (NIMS; North Bay Village, Florida) reported the U.S. Patent and Trademark Office issued Patent No. 7,111,346 for AT-101, its flagship product for therapeutic and diagnostic applications. The company also said it has developed the Exer-Rest, a lower cost version of the AT-101 for home use. The AT-101 is pending FDA approval. A clinical trial is planned for its intended use of temporary relief of musculoskeletal pain associated with osteoarthritis of the hips.

• PLC Systems (Franklin, Massachusetts) said the FDA has granted conditional approval of an investigational device exemption (IDE) to conduct a pilot clinical trial to evaluate the safety of the RenalGuard system and to accurately measure and balance fluid inputs and outputs on patients undergoing a catheterization procedure where contrast media will be administered. RenalGuard is an automated, real-time fluid measurement and replacement system intended to provide balanced replacement hydration therapy to high-risk patients undergoing imaging procedures where contrast agents are administered. PLC develops technologies for the cardiac and vascular markets.

• Preferred Medical Devices (Boca Raton, Florida) reported FDA approval of its UrAssist, a noninvasive, portable and pump-assisted urine collection and containment system designed to reduce the risks of sores, rashes, urinary tract infections and slip-and-fall accidents. UrAssist, about the size of a laptop computer and weighing less than five pounds, can be attached to most wheelchairs, scooters and bedsides. The device is battery-operated and uses a patented pump-assisted technology to draw urine from a collection cup through a plastic tube into a collection bag that stores a day’s amount of urine. This bag is securely stored within the unit, with audio and visual alarms that alert users once the bag is full. The rechargeable battery lasts up to two weeks.

• Radiant Medical (Redwood City, California) reported initiation of its COOL RCN trial, a safety and efficacy study of catheter-based cooling in patients undergoing cardiac catheterization who are at risk of developing radiocontrast nephropathy (RCN). The Reprieve Endovascular Temperature Therapy System is designed to enable the rapid induction of hypothermia in a conscious or unconscious patient by use of a venous heat exchange catheter. A catheter is threaded into the femoral vein and positioned in the inferior vena cava. As cool sterile saline is circulated within the catheter, blood flowing past the catheter is cooled, and the blood then reduces the body temperature. To rewarm the patient, the sterile saline within the catheter is simply warmed. Radiant Medical develops endovascular temperature therapy systems to advance the treatment of patients with acute ischemic or inflammatory medical conditions, such as heart attack, radiocontrast nephropathy, stroke and cardiac arrest.

• Royal Philips (the Netherlands) reported the availability of triplets monitoring functionality for its line of obstetrical care fetal and maternal monitors, Avalon FM20 antepartum and Avalon FM30 intrapartum. Built on Philips’ IntelliVue patient monitoring platform, Avalon FM20 antepartum monitors and Avalon FM30 intrapartum monitors use three channels of high-quality ultrasound tracing and check coincidence between the heart rates of the mother and all fetuses to help ensure each fetus is being monitored. The monitor is designed to display the three fetal heart rates, along with the mother’s heart rate, on a color touch screen. Royal Philips Electronics of the Netherlands is a provider of medical diagnostic imaging and patient monitoring systems.

• Siemens Medical Solutions (Malvern, Pennsylvania) reported the availability of its three-dimensional Stereoscopic Display system designed to allow physicians to more clearly view and better understand vascular structures in the human body. Physicians specializing in angiography are expected to be able to use the system by viewing a 3-D stereoscopic display to improve decision-making for faster and more confident treatments, Siemens said. Mimicking the perception of the human eye, the display creates two or more views of an object to produce a stereoscopic impression delivering depth. The 3-D display enables physicians to provide more efficient treatment for diseases like vascular aneurysms, stenotic narrowing of vessels and vascular malformations, Siemens said.

In a new study presented by Spirations (Redmond, Washington) at CHEST 2006 in Salt Lake City, the 72nd annual international scientific assembly of the American College of Chest Physicians (ACCP; Northbrook, Illinois), the IBV Valve, a nonsurgical, investigational device, was shown to be safe and effective for patients with emphysema. Spirations makes medical devices for the treatment of lung disease, specifically emphysema. ACCP represents 16,500 members who provide clinical respiratory, critical care, sleep, and cardiothoracic patient care worldwide.

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