• Abbott (Abbott Park, Illinois) reported receiving FDA 510(k) clearance for its new, compact hematology instrument, Cell-Dyn Emerald. Abbott said Cell-Dyn Emerald will expand its hematology platform by offering the solution to small to mid-sized clinical laboratories. Emerald's small size, touch-screen software and reliability offer a compact table/bench top instrument for performing complete blood counts (CBC), a test routinely ordered by doctors to assess a patient's overall health and to screen for a variety of disorders such as anemia and infection. With the Emerald, CBC results are completed in 60 seconds and reported in an easy-to-read format with histograms representing white blood cells, red blood cells and platelets, according to Abbott.

• BioImagene (Cupertino, California) has received FDA clearance for its Pathiam system with iScan for assessment of HER2/neu immunohistochemistry tests. The scanner and associated software are used to detect and provide a quantitative measurement of HER2/neu, a protein that is measured in breast cancer patients in order to determine if they are candidates for treatment with the breast cancer drug Herceptin. The iScan is an automated digital slide scanner that provides scanning of slides at 20X and 40X with good image quality. iScan features an autoloader for walk-away scanning of up to 160 slides and an automated slide detection system. iScan is fully integrated with BioImagene's Pathiam digital pathology workflow software to provide a powerful slide management and analysis system. Pathiam provides users with features including a rich menu of validated protocols, digital archiving and retrieval, flexible reporting and easy integration with LIS systems.

• Sensiotec (Atlanta) reported FDA 510(k) Class II clearance for the ultra-wideband (UWB) non-contact, continuous monitor for heart and respiration rates, bed occupancy and movement. Under the brand name Preventa, Sensiotec will market and sell the device in the U.S and Canada under an exclusive worldwide license with its affiliate, Wireless 2000 (Burnaby, British Columbia). Preventa harnesses the potential of UWB, an emerging wireless communications standard and former classified military technology, creating a wireless vital signs monitor.

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