• 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.

• Candela (Wayland, Massachusetts) said it has introduced a new QuadraLASE laser. The QuadraLASE system combines the performance of a CO2 laser with a scanning system giving practitioners a total solution for skin rejuvenation and tightening by treating wrinkles, uneven tone and texture, sun damage, acne scarring, the removal of skin tags, benign lesions and more. Candela will begin sales and marketing activities around the world with launch at next month's annual meeting of the American Academy of Dermatology.

• NextDocs (Philadelphia) reported a major upgrade to the company's Microsoft Office SharePoint Server-based software suite for life sciences companies. Version 3.5 of the NextDocs Regulatory Document Management System includes an entirely new module for managing clinical documents as well as new features that enhance users' ability to easily manage regulated content. Like all NextDocs components, the Clinical Module sits on the NextDocs Compliance Platform and addresses the full set of regulatory requirements such as those prescribed by 21 CFR Part 11.

• Oxygen Biotherapeutics (Costa Mesa, California) said it has plans to file a Phase II, dose escalation, clinical trial protocol in Switzerland for use of Oxycyte in traumatic brain injury (TBI). Oxycyte is the company's perfluorocarbon (PFC) therapeutic oxygen carrier. Chairman/CEO Chris Stern said, "Depending on the timing of the review process there, we could begin enrolling patients in the second quarter."

Neurological surgeons at University of Texas Southwestern Medical Center (Dallas) have begun implanting patients as part of a clinical study that is investigating whether deep brain stimulation (DBS) therapy via the Libra DBS system from St. Jude Medical's Neuromodulation Division (Plano, Texas) may help people who suffer from major depressive disorder, a severe form of depression. The BROADEN (BROdmann Area 25 DEep brain Neuromodulation) study is a controlled, multi-site, blinded, clinical study that is evaluating the safety and effectiveness of DBS therapy in patients with depression for whom currently available treatments are not effective. UT Southwestern is one of three U.S. sites currently participating in this clinical study. The Libra DBS system being evaluated in this study is designed to provide mild pulses of current to a part of the brain called Brodmann Area 25. This area appears to be overactive when people are profoundly depressed. The study is sponsored by St. Jude.

• 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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