• Astro-Med (West Warwick, Rhode Island) said that its Grass Technologies Product Group has received FDA clearance to sell its Neurotrac III neuromonitoring software system. Grass Neurotrac III software received clearance for the intended use of recording the electroencephalogram (EEG) and the computed EEG trends over extended periods of time so that trained health care professionals can observe long-term changes. The company will now begin to sell this existing product for new applications in continuous EEG monitoring. In addition to displaying and recording the traditional EEG waveforms, the Neurotrac III software also computes and displays graphical trends of EEG features such as amplitude integrated EEG trend, frequency trends, and Burst-Suppression Patter trends which aid the physician in identifying changes in brain function over time.

• BK Medical (Herlev, Denmark), a subsidiary of Analogic (Peabody, Massachusetts), has launched its new ultrasound system, the Pro Focus UltraView, for the surgical and urological ultrasound markets. This high-performance ultrasound system uses BK Medical's new IQPAC technology to provide premium images that make a diagnostic difference. The IQPAC technology combines BK Medical's Enhanced Tissue Definition and Angular Compound Imaging technologies to optimize the ultrasound image. Enhanced Tissue Definition intensifies anatomic borders by minimizing speckle, and Angular Compound Imaging uses images from several angles to create a superior compound image. The UltraView system also features a 19" high-definition monitor with scalable image size and a sealed keyboard for easy cleaning.

• Invitrogen (Carlsbad, California) reported the introduction of the BenchPro 4100 Western Processing Device, a benchtop tool developed to automate processing of routine washing and incubation steps for standard laboratory procedures. This device simplifies protein analysis workflows by automating Western blotting; a laboratory technique used in a variety of life science research applications, including studies of antibodies and biological pathways. Western blotting, also referred to as immunoblotting, is a laboratory technique used to detect specific proteins in biological samples through gel electrophoresis. After separation, proteins are transferred to a membrane, where they can be identified using antibodies specific to the protein.

• Iris International (Chatsworth, California) said that it has received Institutional Review Board approval from Duke University Medical Center (Durham, North Carolina) to immediately begin a retrospective clinical study using its NADiA ProsVue ultra-sensitive prostate-specific antigen diagnostic assay. The first stage of the clinical study will use retained serum samples of 30 patients whose prostate cancer relapse, or remission, has been clinically confirmed with imaging data or the patient's death. The ProsVue assay will be independently used in this study to assist the company in furthering the hypothesis that NADiA ProsVue can prognosticate patients as low risk of prostate cancer recurrence. In a previously announced retrospective study of stored leftover serum of 85 post-prostatectomy patients, NADiA ProsVue detected levels of PSA after radical prostatectomy that were undetectable using conventional ultra sensitive assays. In this study, the NADiA ProsVue assay detected a rise of PSA concentration on an average 2-1/2 years before tPSA values reached 100 pg/mL (0.1ng/mL), the sensitivity level of conventional PSA assays.

• Johnson Medtech (Shelton, Connecticut) reported its participation in creating the world's first MRI-compatible image-guided tumor treatment device with Profound Medical (PMI; Toronto). This tissue coagulation device is expected to treat prostate cancer in a fraction of the time and cost of existing methods, based on extensive modeling, simulation and pre-clinical trials. Johnson Medtech's non-magnetic Nanomotion actuators enable the precision of motion and accuracy of treatment necessary for safely conducting the image-guided prostate cancer therapy within the strong magnetic field of the MRI. PMI's device uses an MRI for imaging and a proprietary planar ultrasound applicator for treatment. The MRI precisely guides the probe that heats the cancerous tissue to effectively destroy the diseased area.

• Medicsight (London) said it has received a Request for Additional Information (AI) letter from the FDA. This request is in regard to the 510(k) pre-market notification for the ColonCAD API 3.1 product. The FDA has requested clarification of the intended use of the product. Medicsight is collating the information required, will continue discussions with the FDA and will provide a response to the agency in due course. Medicsight is a subsidiary of MGT Capital Investments, and a maker of computer-aided detection and image analysis software, which assists radiologists in the early detection of disease.

• Olympus Diagnostic Systems (Center Valley, Pennsylvania), a maker of in vitro diagnostics, reported the release of Hemoglobin A1c APT Reagent OSR61177 with fully automated on-board pre-treatment, for the determination of glycated hemoglobin in whole blood samples. HbA1c assays are commonly ordered laboratory tests used to ascertain blood glucose levels over a three-month period. The assay is designed for exclusive use on the Olympus AU680 chemistry analyzer system. The AU680 analyzer features enhanced whole blood sampling for Hemoglobin A1c testing, enabled by both advanced sample probe diving depth and enhanced sample probe washing. On-board pre-treatment is supported by the sample pre-diluting capability of the system.

• Opko Health (Miami) has received FDA clearance to begin marketing its Spectral OCT SLO Combination Imaging System. With the Spectral OCT SLO, high-resolution images are produced with inner retinal choroid and vitreous detail that allow for improved monitoring of ophthalmic disease progression or regression. The Spectral OCT SLO is a non-contact, high-resolution non-invasive tomographic and confocal imaging device indicated for in vivo viewing, axial cross-sectional, and three-dimensional imaging and measurement of posterior ocular structures including: retina, macula, retina nerve fiber layer and optic disk. It is used as a diagnostic device to aid in the detection and management of ocular diseases affecting the posterior segment of the eye. Separately, Opko Health said it has begun treating patients in a clinical trial of its Aquashunt, a device for the treatment of refractory open angle glaucoma. The study is designed to assess the safety and efficacy of the Aquashunt and will enroll up to 20 patients with significantly impaired visual acuity. The Aquashunt is a device designed to lower intraocular pressure by allowing excess fluid in the eye to exit more naturally than occurs with presently available devices.

• Royal Philips Electronics (Andover, Massachusetts) has launched a new ultrasound system, which focuses on helping clinicians deliver high quality care for a full range of women's health needs. The HD9 system combines advanced imaging technology, including 3-D and 4-D capabilities, in an easy-to-use and reliable system for obstetrics, gynecology and breast imaging. The HD9's features include: Philips Live iSlice, which enables clinicians to focus on specific areas of interest within a volume and find images with the best views and content, making for more confident diagnoses; Spatio-Temporal Image Correlation (STIC) to evaluate fetal heart anatomy and function by allowing clinicians to create a volume image that can be displayed and interrogated during playback; Tissue Specific Imaging technology additionally allows the system to be optimized for a specific patient or examination type, to provide excellent imaging quality with little need for optimization.

• Varian Medical Systems (Palo Alto, California) and BrainLAB (Munich, Germany) reported the introduction of the Novalis Tx platform which enables doctors to perform image-guided radiosurgery on tumors of the lung, as well as of the brain, spine, liver, and prostate, without making a single incision. Novalis Tx performs stereotactic body radiotherapy (SBRT), a form of non-invasive radiosurgery that uses precisely-shaped and targeted radiation beams to treat tumors and non-malignant growths from outside the body. The Novalis uses a linear accelerator, which rotates around the patient to target surgical beams at tumors from virtually any angle. A set of sophisticated image guidance and motion management tools provide clinicians with detailed information about the shape, size, and position of the targeted lesion, guide patient set up and positioning, and monitor motion during treatment.

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