Regulatory news from: IMCO, Mercury Computer

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IMCO Technologies has submitted its IMCO-STAT communications technology software for clearance with the U.S. FDA. IMCO-STAT communicates critical findings utilizing voice, hand-written text, typed text in pre-formatted reports, key images with annotations and streaming video. The system does so using bi-directional communication. IMCO-STAT includes the capability of sending results via a wireless environment to tablet PCs, PDAs and/or to hard-wired workstations. Recipients of incoming messages receive audible alerts and the receipt status is confirmed back to the sender. IMCO hopes to obtain FDA clearance to bring IMCO-STAT to market in the U.S. early next year.

Mercury Computer Systems has granted clearance to market Visage PACS and Visage CS (client server) products as medical devices in the United States. In June, Mercury's Commercial Imaging and Visualization group received ISO 13485 certification for its quality management system for medical devices.
Mercury also announced a three-year deal with Los Angeles-based Genesis Digital Imaging that supports distributors in the North American medical imaging industry with products and services. Per the terms, Genesis will distribute Mercury's Visage web-enabled PACS under its product umbrella Omni-WEB PACS.