• Escalon Medical (Wayne, Pennsylvania) said that its Drew Scientific subsidiary received FDA clearance to market the D3 Hematology System, an automatic three-part differential hematology analyzer. The D3 uses advanced technology for superior reliability of 3-part differential blood analysis. Features of the analyzer include low reagent consumption and very small sample size to minimize laboratory waste, a built-in color touch screen, providing on-screen histograms and storage of up to 500 records and QC statistics, and multi-language capability. Drew Scientific is a diagnostics company specializing in the design, manufacture and distribution of instruments for blood cell counting and blood analysis. Escalon makes ophthalmic diagnostic, surgical and pharmaceutical products as well as vascular access devices.
  • ev3 (Plymouth, Minnesota) reported the U.S. launch of the company's most recent additions to the SilverHawk family of products: the SilverHawk LS-M and MS-M. These devices are among the latest in plaque excision technology and are designed to treat lesions in arteries above the knee for patients suffering from peripheral artery disease. The LS-M and MS-M include MEC (micro efficient compression) technology, an advancement which features precision laser-drilled vent holes in the tip of the catheter. These micro vent holes release fluid pressure, providing more space for the collection of tissue in the tip of the device. This technology has the potential to reduce overall procedure time by enabling physicians to increase tissue collection during plaque removal procedures in large vessels above the knee. ev3 makes endovascular therapies.
  • Iris International (Chatsworth, California) said that it has submitted a 510(k) application with the FDA for clearance to market its iChem Velocity automated urine chemistry analyzer using the company's proprietary kinetic imaging technology — an imaging system that will optimize the sensitivity and dynamic range of the company's urine chemistry strips. The Velocity is designed for medium-to-high volume laboratories that typically process more than 100 urine samples per day. Iris International makes diagnostic imaging systems.
  • SonoSite (Bothell, Washington), developer of point-of-care, hand-carried ultrasound devices, reported it has begun worldwide shipments of its S Series ultrasound tools. Based on the company's fourth generation technology platform, the S Series product line combines the processing power, image quality and advanced data management features of SonoSite's M-Turbo system with a customized user interface to address the specific needs of four clinical specialties.