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Koning recibe la marca CE para el Koning Breast CT 3D de alta resolución


News provided by

Koning Corporation

29 Feb, 2012, 05:55 GMT

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WEST HENRIETTA, Nueva York, February 29, 2012 /PRNewswire/ --

El primer Cone Beam Breast CT aprobado para el diagnóstico de imagen de la mama

Koning Corporation, un desarrollador líder de sistemas de imagen médica avanzada que combina las ventajas de rayos-X digitales y tomografía computerizada llamada Cone Beam Computed Tomography (CBCT) anunció hoy que ha obtenido la aprobación de marca CE para su sistema Koning Breast CT (KBCT). Esta aprobación significa que KBCT cumple con la legislación de la Unión Europea (UE) y las regulaciones de dispositivos médicos permitiendo su comercialización y venta en la UE y otros países que reconocen la marca CE.

(Logo: http://photos.prnewswire.com/prnh/20120227/NY60584LOGO)

"Esta aprobación de marca CE representa un paso importante para la imagen de la mama y el cuidado de la salud de las mujeres, en general," dijo Ruola Ning, PhD, director general y fundador de Koning, un pionero y experto líder en tecnología Cone Beam CT. "KBCT es el ultimo avance en la tecnología de imagen de la mama en 3D y se centra en un cada vez mayor asunto mundial de la salud de las mujeres, la detección precoz y diagnosis del cáncer de mama. El cáncer de mama afecta a cientos de miles de mujeres y es una de las formas más comunes de cáncer en Norteamérica, Europa y China. Estamos orgullosos de proporcionar esta revolucionaria tecnología para el beneficio de las mujeres de todo el mundo."

KBCT es el primer escáner CT comercialmente disponible, totalmente integrado, dedicado al cáncer, diseñado específicamente para tomar imágenes de toda la mama con alta resolución espacial y contraste a una dosis de radiación similar a o menos que la mamografía de diagnóstico. El sistema adquiere un conjunto de imágenes en diez segundos produciendo imágenes 'reales' 3D y cortes multi-planos de cruce seccional. Comparado a la mamografía de diagnóstico 2D actual con buenas limitaciones reconocidas, KBCT elimina virtualmente la superposición de tejido y la superimposición de estructuras, que son a menudo responsables del fallo en el diagnóstico del cáncer de mama precoz, que es más tratable, salvando vidas y reduciendo los costes de asistencia sanitaria.

Acerca de Koning

Koning Corporation, fundada en 2002, es una compañía de imagen médica internacional con oficinas en West Henrietta, Nueva York y Tianjin, China (Koning Tianjin Medical Equipment Co. LTD), que desarrolla y comercializa Cone Beam CT Scanners "de vanguardia" para la detección, diagnóstico y tratamiento de enfermedades y otras aplicaciones médicas. El desarrollo de la tecnología y sistema Koning breast CT ha estado apoyado en parte por una beca NIH/NCI SBIR (1R44 CA103236 ) y SBIR Bridge Grant (2R44 CA 103236-05 ). Esas becas se benefician de las licencias de patentes y desarrollos de la University of Rochester bajo la beca NIH/NCI 1R01CA085904 que desarrolló un concepto para el haz de luz de cono CT, y una beca 1R21/R33CA094300 exploratoria/en desarrollo que exploró el potencial del concepto del haz de luz de cono CT para la imagen mejorada de la mama. Koning Corporation está actualmente a la espera de aprobación por parte de la FDA en EE.UU., aprobación SFDA en China y Canada Medical Device License. Koning Corporation empezará la comercialización de los sistemas KBCT en Europa. Para conseguuir esas aprobaciones regulatorias, la distribución se ampliará a Estados Unidos, China, Canadá y otros mercados internacionales.

Información de contacto

      John Neugebauer                     David Conover
      VP ventas y marketing               Relaciones públicas y comunicaciones
      Tel: +1-585-214-2459                Tel: +1-585-214-2459

      john.n@koningcorporation.com        david.conover@koningcorporation.com
      http://www.koningcorporation.com    http://www.koningcorporation.com

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