FDA Approved!
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| The NeoGuide Endoscopy System, designed to eliminate looping, is built out of multiple segments that can be actively controlled. The system creates a 3-D map of the colon and then directs these segments to follow the path taken by the tip. |
NeoGuide Systems Inc (Los Gatos, Calif) has received FDA 510(k) clearance to market its NeoGuide Endoscopy System. The system is designed to enhance physician control of the colonoscope and to eliminate looping, the principal reason why conventional colonoscopy procedures are painful, time-consuming, and difficult. NeoGuide successfully completed its initial clinical study with the system in September 2005 at Klinikum der Stadt Ludwigshafen in Germany. The company also has conducted extensive studies demonstrating the safety of the system and the potential to reduce looping in various benchtop models.
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| The 4-megapixel wide-screen color display from Planar features a 600:1 contrast ratio, 330 cd/m2 typical brightness, and automatic DICOM calibration. |
Planar Systems Inc (Beaverton, Ore) has received FDA 510(k) clearance for its Dome E4c, the first 4-megapixel color display medically certified for the viewing of diagnostic images. The Dome E4c's wide-screen display, part of Planar's recently introduced Dome EX line, can increase efficiency and productivity in radiology, cardiology, nuclear medicine, PET/CT, and more. New features, such as its 16:9 display format, offer more screen space and the ability to show 15 full-size 512 x 512 images on one screen.
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| The Mammomat Novation DR from Siemens Medical is now approved by the FDA for use in the state of Iowa. |
The FDA has approved Iowa to accredit the Mammomat Novation DR full-field digital mammography units from Siemens Medical Solutions (Malvern, Pa) within the state. Worldwide, Siemens Medical has installed more than 100 systems, which provide digital images that aid clinicians in screening, diagnosis, and stereotactic biopsy capabilities in one system.
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