• Analogic (Peabody, Massachusetts) reported that the FDA has given market clearance for the FetalGard Lite-NIBP (Non-Invasive Blood Pressure) fetal monitor. The FetalGard Lite-NIBP measures maternal non-invasive blood pressure for monitoring pregnancy-induced hypertension in addition to providing standard fetal monitoring capabilities. The device offers "beat-to-beat" fetal heart rate analysis on twins, and measures maternal uterine activity and blood pressure. It is portable, battery-operated, and weighs five pounds, making it appropriate for use in a variety of settings. The company said the FetalGard Lite-NIBP also offers the first alternative to Z-fold paper because it can store and transfer tracings to a PC for viewing, reporting and printing. Alternatively, multiple patients' records can be stored and subsequently "fast printed" to an Analogic Z-fold recorder when hard copies are needed for review or patient records.

• GeneFluidics (Monterey Park, California) said research reported in the February Journal of Clinical Microbiology investigated its biosensor technology in the diagnosis of urinary tract infections (UTI) – the second-most-common bacterial infection – in a clinically relevant timeframe. Researchers used GeneFluidics' biosensor, coated with species-specific genetic probes designed at University of California, Los Angeles, to correctly identify the infection-causing gram-negative bacteria species in 98% of the tested clinical UTI urine samples. These results represent the first ever species-specific detection of bacteria in human clinical fluid samples using a microfabricated electrochemical sensor array, the company said. The test provided results in 45 minutes, compared to two days with conventional methods. GeneFluidics said it anticipates the rapid test may be available in the next two to three years.

• Genzyme Genetics (Cambridge, Massachusetts) reported the availability of a new test to monitor drug resistance in chronic myeloid leukemia patients who are treated with Gleevec (imatinib mesylate) from Novartis (Basel, Switzerland). Despite high response rates to Gleevec, about 4% to 5% of patients who were initially treated successfully will develop resistance during therapy. Genzyme's BCR-ABL Mutation Analysis test, which detects all secondary BCR-ABL mutations to predict resistance to Gleevec, will assist physicians in evaluating resistance to therapy and facilitate appropriate adjustments to treatment.

• Medwave (Danvers, Massachusetts), a provider of sensor-based, non-invasive blood pressure measuring solutions, reported that it has received FDA marketing clearance to sell its Primo hand-held spot blood pressure monitoring device. With accuracy the company said is comparable to an invasive arterial catheter, Primo is placed on the wrist. The user presses a start key, and within about 12 seconds, blood pressure and pulse rate values are displayed. Compact and lightweight, Primo is comfortable for the patient, easy to use and requires no calibration or routine maintenance, Medwave said.

• Nellcor (Pleasanton, California) said it is now offering the OxiMaxx N-60 pulse oximeter, which it said is the new flagship monitor in its OxiMax pulse oximetry system. The company said its digital signal-processing technology enables the OxiMax N-600 pulse oximeter to deliver accurate measurements even in conditions of low perfusion and signal interference. The LoSat expanded accuracy feature of its OxiMax adhesive sensors assures a wide accuracy range when used with the OxiMax N-600. Nellcor's SatSeconds alarm management technology in the OxiMax N-600 offers a safe, practical way to reduce nuisance alarms. The OxiMax N-600 is compatible with the complete line of OxiMax adhesive, reusable and specialty sensors, and can be networked to Nellcor's remote oximetry alarm systems for improved patient safety in lower-acuity areas. The OxiMax N-600 has the same dimensions and user interface as the previous model for seamless integration without requiring additional training. The new OxiMax N-65 hand-held pulse oximeter also is available, Nellcor said, providing a portable option with the same advanced signal-processing performance as the OxiMax N-600.

• SenoRx (Aliso Viejo, California) said that more than 30 healthcare institutions are now capable of performing MRI-guided biopsy procedures using its EnCor Multi-Modality, Modular Biopsy System. EnCor is the first fully programmable, automated, multi-modality, modular breast biopsy system available representing the next generation of technology in breast disease diagnosis. Additionally, SenoRx has three new 510(k)-cleared products scheduled to launch in the next 18 to 24 months.

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