• American Medical Systems (Minnetonka, Minnesota) reported FDA clearance and CE mark for its MiniArc Single Incision Sling System, a treatment for female stress urinary incontinence. The system involves a single incision procedure designed to reduce operative invasiveness and enhance patient recovery. It is designed for use in the operating room; however, its low-profile design and simple procedure may also make it appropriate for in-office use, the company said. American Medical Systems supplies medical devices for erectile dysfunction, benign prostatic hyperplasia, incontinence, menorrhagia, prolapse and other pelvic disorders in men and women.

• Criticare Systems (Waukesha, Wisconsin) reported the launch of the communication interface between Criticare's VitalCare portable vital signs monitor and Sensitron's careTrends software solution, developed to enable acute care customers to wirelessly transfer patients' vital signs data into their network. This new interface was shown at the Sensitron booth at the annual Health Information Management Systems and Society (HIMSS) Conference in New Orleans last month. The integration will provide a wireless solution to transfer patients' vital signs such as heart rate, blood pressure, temperature and respiration into a hospital's electronic medical record (EMR). Criticare Systems manufactures monitoring systems for oral and maxillofacial surgery. Sensitron (San Mateo, California) develops wireless patient monitoring systems.

• E-Z-EM (Lake Success, New York) said that the Joint Program Executive Office for Chemical Biological Defense (JPEO-CBD) of the U.S. Department of Defense (DoD) has determined that RSDL has satisfied all final configuration testing criteria, and is approved for initial procurements by the individual service branches. The decision, known as Milestone C, clears the way for deployment of RSDL to war-fighters as the DoD's next generation skin decontaminant for protection against chemical weapons (CW) agents. RSDL is a patented, broad spectrum skin decontamination product intended to remove or neutralize chemical warfare (CW) agents or T2 toxins from the skin.

• Immucor (Norcross, Georgia), which provides automated instrument-reagent systems to the blood transfusion industry, said on Friday, the company submitted the 510(k) premarket notification submission for its Galileo Echo instrument to the FDA. Immucor makes a line of reagents and systems used by hospitals, reference laboratories and donor centers to detect and identify certain properties of the cell and serum components of blood prior to transfusion. Immucor markets a family of automated instrumentation for all of its market segments.

• Lifeline Biotechnologies (Reno, Nevada) said the new experimental classifying algorithms, the basis for Lifeline's First Warning System for breast cancer, demonstrate sensitivity of 100% (the ability to find lesions in the breast) and two additional algorithms documented a specificity (the ability to distinguish benign from cancerous lesions) of 84% and 91% with its new neural network system which is nearing readiness for clinical testing on large patient data sets.

• Medicaa (Montevideo, Uruguay) reported development of a new application for eMagin's (Bellevue, Washington) Z800 3DVisor. The medical hardware developer has integrated the gaming device into its Balance Rehabilitation Unit (BRU), for treating patients with balance disorders, vertigo or instability. Approved earlier this month by the FDA, the BRU uses the Z800 3DVisor to selectively stimulate the neural processes involved in the vestibular compensation mechanisms.

• MedicalCV (Minneapolis) reported FDA 510(k) clearance for its Solar Surgical Ablation System for the ablation of soft tissue. MedicalCV developed the Solar System to enable automated, computer-controlled ablation in surgical procedures using laser energy. The company makes surgical ablation systems that utilize a laser energy technology platform to create precise lesions, or scars, on soft and cardiac tissues. The company's core technologies are the Solar and Atrilaze Surgical Ablation Systems for use in soft and cardiac tissue ablation procedures, respectively.

• Medtronic (Minneapolis) reported launch of the Guardian Real-Time System, a doctor-prescribed, personal, continuous glucose monitoring (CGM) system for improved diabetes management. The Guardian Real-Time System will include the MiniLink REAL-Time Transmitter — a rechargeable, waterproof transmitter approximately one-third the size of previous Medtronic transmitters. The Guardian Real-Time System also will incorporate the Medtronic CareLink Personal Therapy Management Software, which integrates data from the patient's Guardian REAL-Time System, logbook and blood glucose meter to identify patterns and trends in glucose management.