• Biosense Webster (Diamond Bar, California) said the FDA cleared for marketing under a 510(k) application a technology designed to help physicians diagnose and plan treatment for patients with cardiac arrhythmias. The Carto RMT V8 System from Biosense Webster and the Niobe Magnetic Navigation System from Stereotaxis (St. Louis) provide electrophysiologists with automated 3-D mapping and navigation tools, and a magnetic steering platform. Among the enhanced offerings of the system integration are real-time feedback in guiding the catheter to the target, as well as simultaneous display of the NaviStar RMT Catheter on Carto RMT System and Niobe Screens, and bi-directional communication between the two technologies. The new system and catheter provide greater efficiency and better signal resolution, reduced redundancy in data entry and increased reproducibility through automation, the company said.

• SPO Medical (Woodland Hills, California), a developer of biosensor and microprocessor technologies for use in portable monitoring devices, reported the commercial launch of its FDA-approved and CE-marked PulseOx 7500, a compact, wrist-mounted oximetry system designed to monitor the vital signs of people experiencing sleep disorder symptoms. A sensor is placed at the tip of the finger to measure oxygen saturation and heart rate. It is connected to a watch-like, wrist-mounted monitor that collects and stores data over extended periods of time, including overnight while the wearer sleeps. Data can be downloaded by the physician for analysis via the sleep apnea reporting software and connecting cables supplied with each unit.

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