Healthcare Industry News:  Criticare Systems 

Devices Monitoring Regulatory

 News Release - December 4, 2007

Criticare Announces the MEDRAD(R) Veris(R) MR Monitoring System is Approved for Marketing in Japan

MILWAUKEE--(HSMN NewsFeed)--Criticare Systems, INC. (AMEX:CMD ). Criticare Systems, Inc. today 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.

This press release contains forward-looking statements. Such statements refer to the Company's beliefs and expectations. Forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those described. Such uncertainties include, but are not limited to, the timely completion of new products, regulatory approvals for new products, the risk of new and better technologies, risks relating to international markets, as well as general conditions and competition in the Company's markets. Other risks are set forth in Criticare's reports and documents filed from time to time with the Securities and Exchange Commission.

Source: Criticare Systems

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