Guava Technologies (Hayward, California), an on-demand, benchtop cell analysis systems company, reported that it was successfully audited to the requirements of ISO13485:2003 by BSI Management Systems. With this certification, the company will redouble efforts on medical devices for the international market, covering a variety of therapy areas, beginning with HIV/AIDS.
ISO is a network of the national standards institutes of 157 countries, and ISO 13485 is an internationally recognized standard to establish the quality management systems applicable to manufacturers of medical devices. It is harmonized to FDA 21 CFR part 820.
"We are proud to receive this international recognition," said Lawrence Bruder, president/CEO. "It's a clear indication of our ability to consistently meet regulatory and customer requirements for medical devices, and reflects our intense commitment to the highest possible standards for design, development, manufacture, and service for all of our products."
Medwave taken off NASDAQ listing
Medwave (Arden Hills, Minnesota) said that it has been advised by NASDAQ that its common stock will no longer be traded on the NASDAQ Capital Market beginning with the opening of trading on July 17. The company is currently seeking a market maker to apply for its common stock to be quoted on the OTC Bulletin Board.
The company had received notice from NASDAQ on Jan. 5 that the company's common stock had fallen below the NASDAQ Capital Market's minimum bid price standard for continued listing as set forth in Marketplace Rule 4310(c)(4) (Medical Device Daily, Jan. 24, 2007). The rule requires that a company's common stock trade at a minimum average closing share price of $1 during a consecutive 30-day trading period. The company was provided 180 days to regain compliance with the rule. The company was unable to raise the share price of its common stock to above $1 during this period. Medwave makes sensor-based non-invasive blood pressure solutions.