• Cholestech (Hayward, California), a manufacturer of point-of-care lipid diagnostic testing devices, has received clearance from the FDA to market the high sensitivity C-reactive protein (hs-CRP) test on the Cholestech LDX System for the measurement of CRP in whole blood or serum. The new test is expected to be available in late summer. The company noted that a landmark study published in a recent issue of the Journal of the American Medical Association said that hs-CRP is as strong a predictor of cardiac risk as conventional risk factors such as cholesterol. The study, conducted at Brigham and Women’s Hospital (Boston), also showed that hs-CRP adds predictive value when used in conjunction with lipid tests related to cholesterol. The study followed nearly 16,000 women aged 45 and older for 10 years, monitoring them for the occurrence of a first cardiovascular event. It demonstrated that women with the highest levels of hs-CRP had a three-fold increase in risk.

• Criticare Systems (Milwaukee, Wisconsin) said it has received FDA approval to market its new portable cardiac monitor. It said the advanced system is intended to monitor physiological parameters of patients within any healthcare environment. The company said the monitor’s design allows a wide variety of optional configurations so it can be tailored for specific market requirements worldwide. The system incorporates certain oxygen saturation and temperature measurement technologies as options to satisfy specific clinical and economic requirements. Criticare said it will launch the system during the current fiscal quarter.

• DexCom (San Diego) reported receiving a patent covering the fail-safe mechanism that evaluates the clinical acceptability of continuous glucose sensor data for providing patients with real-time continuous glucose data. DexCom has experience in conducting clinical trials in which patients have been allowed to view and utilize the real-time data from its continuous glucose monitoring systems.

• Siemens Medical Solutions (Malvern, Pennsylvania) has received FDA 510(k) clearance for the Arcadis Avantic, a new mobile C-arm system. The new mobile surgery C-arm is best suited for advanced imaging requirements in trauma and spine surgery, general surgery and urology, orthopedic surgery and pain management, gastroenterology and vascular surgery. The Avantic has 20 kW of power – the strongest in the industry, according to the company – up to 250 mA output and a 13-inch image intensifier. The new design also features reduced weight and smaller footprint requirements, Siemens said. A compact, swiveling operating panel and color-coded brake and control elements enable easy system movement and operation, according to the company. The product is based on syngo, Siemens’ intuitively operated software platform for different modalities. The Arcadis Avantic is expected to be ready for delivery next month.

• TriPath Imaging (Burlington, North Carolina) and Ventana Medical Systems (Tucson, Arizona) said that TriPath has received 510(k) clearance from the FDA for the Ventana Image Analysis System (VIAS) when used with tissues stained for HER-2/neu. HER-2/neu protein analysis aids in the management of breast cancer patients and is used by physicians to aid in prognosis and prediction of therapy outcomes for breast cancer. In May, the companies reported 510(k) clearance for VIAS when used with the Ventana Estrogen Receptor and Progesterone Receptor assays.

• Zonare Medical Systems (Mountain View, California), a developer of ultrasound technology, said it has released the first major upgrade for its z.one ultrasound system. The new release comes less than four months after the z.one system started commercial shipment and features advancements in 2-D imaging, color and power Doppler performance, dual-screen imaging and significant additions to network connectivity. With the latest release, upgrades can now be downloaded via the Internet, which the company said is an industry first. One of the first commercial upgrades was downloaded via the Internet to a z.one ultrasound system at Mercy Hospital (Chicago). The z.one system is based on the company’s Zone Sonography technology, a new architecture that Zonare Medical said has allowed it to bring the first Convertible Ultrasound platform to the industry.

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