MEDRAD Veris MR Monitoring System Approved For Marketing In Japan

Milwaukee - Criticare Systems, Inc. recently announced that Criticare and MEDRAD, INC. received the last required approval by the Japanese Pharmaceutical and Medical Device Agency (PMDA) on November 26, 2007 to import and market the Veris MR Vital Signs Monitoring system in Japan. The Veris MR Monitor was jointly developed by Criticare and MEDRAD, is manufactured by Criticare, and will be marketed through an agreement with MEDRAD.

The PMDA, which maintains regulatory oversight similar to that of the U.S. Food and Drug Administration, granted Japanese Good Manufacturing Practice approval, clearing the final hurdle for entrance into the Japanese market. MEDRAD and Criticare previously obtained approval from Shonin, which reviews a product's operation, safety, and labeling.

Bringing the Veris MR Monitor to the Japanese market is an important milestone for both Criticare and MEDRAD and represents an exciting opportunity for continued growth of the MR Patient Monitoring business.

Criticare designs, manufactures, and markets cost-effective patient monitoring systems and noninvasive sensors for a wide range of hospitals and alternate health care environments throughout the world.

SOURCE: Criticare Systems, Inc.