Criticare Systems OEM Partner Fukuda Denshi CO, LTD. Receives Japanese GMP Approval

Main Category: Medical Devices
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 18 Feb 2008 - 5:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

Criticare Systems, Inc. and OEM partner Fukuda Denshi Corporation announce receipt of approval by the Japanese Pharmaceutical and Medical Device Agency (PMDA) to sell and market CSI gas technology in Japan.

The PMDA, which maintains regulatory oversight similar to that of the U.S. Food and Drug Administration, granted Japanese Good Manufacturing Practice approval, enabling the sale of CSI's gas technology in the Japanese market. This represents an important milestone for both Criticare Systems and Fukuda Denshi providing an exciting opportunity for continued growth of the gas monitoring business.

Fukuda Denshi Corporation is a premier global marketer of a wide range of medical devices.

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. Criticare does not believe its backlog of any date is indicative of its future sales. Other risks are set forth in Criticare's reports and documents filed from time to time with the Securities and Exchange Commission.

Criticare Systems