• A study published in the British Journal of Urology International showed that Advanced Medical Diagnostics (Waterloo, Belgium) HistoScanning technology has high accuracy in the characterization and localization of prostate cancer foci, according to the company. HistoScanning is a diagnosis support tool designed to detect, visualize and characterize cancers in solid organs. It is used in conjunction with specific commercially available ultrasound systems capable of acquiring and transferring so called volumetric radio frequency data. The tissue characterization algorithms can either be applied to discrete regions of interest or the entire scanned tissue volume. Suspicious areas are highlighted in HistoScanning’s 3-D image viewer.
• Ingen Technologies (Nyucaipa, California) said that OxyAlert is expected to receive an “exempt” status from the 510(k) filing in 60 days. OxyAlert is a new medical technology that uses wireless communication to send information related to the status of an oxygen delivery system to a remote receiver. Using a special microchip referred to as ZigBy, OxyAlert complies with the medical standards for wireless communication, and at the same time provides patients and caregivers the ability to distance themselves from the oxygen delivery system and still monitor the amount of oxygen being delivered. Ingen Technologies is a medical device manufacturer.
• Nanosphere (Orthbrook, Illinois) said that it has received clearance from the FDA for the Verigene F5 / F2 / MTHFR nucleic acid test, which detects disease-associated gene mutations that can contribute to blood coagulation disorders and difficulties metabolizing folate (vitamin B-12). This marks the second nanotechnology-based assay cleared by the FDA to run on the Verigene system, following clearance in september of the company’s Verigene warfarin metabolism nucleic acid test. The test is the first FDA-cleared test for the identification of mutations in three specific genes that together can increase an individual’s risk for dangerous blood clots and their leading complication, stroke. The test is available in single and multi target (multiplex) formats, allowing users to select the test cartridge that best fits the clinical indications for testing. Nanosphere is a nanotechnology-based molecular diagnostics company.
• Northstar Neuroscience (Seattle) said that the last patient in the company’s EVEREST trial for stroke motor recovery completed four week follow-up, the primary endpoint for the trial. EVEREST is a national, multi-center, single-blinded, randomized clinical trial investigating whether Northstar’s Renova-ST cortical stimulation system in conjunction with physical rehabilitation improves hand and arm function in stroke survivors compared to those receiving physical rehabilitation alone. The trial is being conducted at 21 stroke centers throughout the U.S. and when complete will include data from more than 150 subjects. Northstar is focused on developing neurostimulation therapies to treat neurological injury, disorder and disease.