• BioSphere Medical (Rockland, Massachusetts) said that it has received CE Mark approval for transarterial chemoembolization of hepatocellular carcinoma (HCC) using HepaSphere microspheres and doxorubicin. Standard transarterial chemoembolization (TACE) is a two-stage process involving the injection of a concentrated dose of chemotherapeutic drugs, e.g. doxorubicin, directly into the blood vessels supplying a tumor, followed by the infusion of an embolic agent through a catheter and into the blood vessels that feed a tumor, thus selectively blocking its blood supply. Because the blood vessels are blocked with the embolic material, the chemotheraptic drug is thought to dwell in direct contact with the tumor longer and target the tumor more effectively than a systemic chemotherapeutic treatment would. Thus, with chemoembolization the drug concentration has been measured to be 20 to 200 times greater within the tumor, compared to chemotherapy administered systematically. BioSphere Medical uses bioengineered microspheres to treat uterine fibroids, hypervascularized tumors, and vascular malformations by a minimally invasive, image-guided medical procedure called embolotherapy.

• 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.

• 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.

• Siemens Medical Solutions Diagnostics (Deerfield, Illinois) reported the introduction of the MicroScan WalkAway plus systems for mid- and high-volume clinical diagnostic microbiology laboratories. The systems offer simultaneous automation of overnight, rapid and specialty panels that test for both gram negative and gram positive bacteria. The WalkAway also offer automation features that improve laboratory productivity by decreasing system maintenance activity. The two new instrument models - a 40- panel capacity model for medium-volume laboratories and a 96-panel capacity model for high-volume laboratories will replace the current WalkAway SI 40 and 96 Systems. Siemens Medical Solutions Diagnostics offers healthcare providers the broadest range of diagnostic products and services that are used for diagnosing medical conditions, monitoring patient therapy and providing quality healthcare.

• 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. John Oropello, MD, professor of surgery and medicine, program director, critical care medicine and co-director, neurosurgical – ICU, Mount Sinai School of Medicine (New York). “We evaluated a lot of machines and no one else has taken into account what critical care physicians need. Both the S-ICU and M-Turbo have superb image quality and are easy to clean–so essential to infection control.” The S Series product line includes the S-FAST for emergency medicine physicians, the S-Nerve for anesthesiologists, the S-Cath for interventionalists and the S-ICU for intensivists.

• Telemedicus (Houston) said it will begin final testing of its technology for fixed/remote and ambulance based systems in anticipation of market launch in early 2008. Telemedicus’ disaster relief and emergency medical services (DREAMS) technology turns practically any ambulance or medical transportation vehicle into a mobile trauma center. The doctor is able to provide treatment immediately through the medical technician because the doctor can see the patient and diagnostic data through the Telemedicus system. Telemedicus makes life saving mobile medical communications technology.

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