• 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.

• BioLok International (Deerfield Beach, Florida), a manufacturer of dental implant technology, reported that it has submitted a 510(k) application with the FDA for the registration of claims to market its bone augmentation material, BoneGen-TR. BoneGen-TR is a time-release calcium sulfate product. BioLok said it also intends to explore opportunities to market BoneGen-TR for uses outside of dentistry.

• Cynosure (Westford, Massachusetts), a manufacturer of lasers and pulsed light sources, reported the introduction of its new Affirm product, a multi-energy system for skin rejuvenation, including treatments for wrinkles, skin texture and discoloration. The Affirm system, which recently received FDA clearance, will be introduced at the American Academy of Dermatology conference in San Francisco in March, and will be launched at the American Society of Lasers in Medicine and Surgery conference in Boston in April. The company said Affirm is the first to combine multiple energy sources in one platform to provide treatment for wrinkles, micro-rejuvenation and skin discoloration.

• GenVec (Gaithersburg, Maryland) reported the publication of results from a Phase I clinical study of its AdPEDF gene therapy in 28 patients with advanced neovascular age-related macular degeneration. The findings, published in the February issue of Human Gene Therapy, showed evidence of a halt in disease progression lasting six to 12 months after patients received a single intravitreous injection of AdPEDF. There were no serious adverse events, severe ocular inflammation or dose-limiting toxicities reported. AdPEDF is an adenoviral-based vector containing the gene for human pigment epithelium-derived factor, a protein that regulates blood vessel growth in the eye and protects the cells of the retina from damage.

• 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.

• Hoana Medical (Honolulu), which develops sensing technology for patient safety, reported that it has received FDA 510(k) clearance to begin marketing its flagship product, the LG1 Intelligent Medical Vigilance System. The LG1 system is a patient safety technology that tracks heart rate, breath rate and whether the patient is in bed or trying to exit the bed. The technology uses advanced digital signal processing software algorithms. Initially, Hoana said it would focus sales efforts on the medical-surgical areas of the hospital.

• HydroCision (Billerica, Massachusetts) said a multi-center study demonstrated that the company's fluidjet-based instruments removed nearly 96% more soft tissue from the difficult-to-access posterior contralateral region than conventional surgical instruments in preparation for spinal fusion. HydroCision's HydroSurgery system, including SpineJet XL instruments, uses a high-velocity stream of water to simultaneously cut and aspirate damaged tissue from spinal discs in preparation for fusion. The technique's advantages, illustrated by the study conducted on cadaver models, include the safe and more effective removal of degenerated disc-nucleus material and endplate preparation that can lead to optimal clinical outcomes. The company also said use of its HydroSurgery system required 65% fewer passes into, and out of, the disc space than conventional surgical instruments.

• Nellcor (Pleasanton, California) is 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.

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