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www.fdanews.com/articles/75812-cardiac-science-gets-japanese-approval-for-aed

CARDIAC SCIENCE GETS JAPANESE APPROVAL FOR AED

August 26, 2005

Devicemaker Cardiac Science has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market a biphasic version of its automatic external defibrillators (AEDs) in Japan.

This approval signals the end of a two-year review process that, Cardiac Science said, allowed a competitor with an approved product to capture some of its market share. Its new approval will enable the company to "get aggressively back on the playing field," said Cardiac Science Chairman and CEO Raymond Cohen.

Nihon Kohden will market the biphasic AED product in Japan under the CardioLife brand name. The approval will allow Cardiac Science to begin realizing significant sales in Japan in the fourth quarter of 2005 and into 2006 and beyond, the company said.

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