Mindray receives US clearance for portable ultrasound system and analyzer

7 April 2008

Mindray Medical International Limited (NYSE:MR), a Shenzhen, China-based medical device company, has received US FDA 510(k) clearance for its M5 portable ultrasound imaging system and BS-200 automatic bio-chemistry analyzer.

The company also announced it has received approval from the Chinese State Food and Drug Administration (SFDA) for the M5 and its DC-3 colour ultrasound imaging system.

The M5 is the company's first laptop-size ultrasound imaging device. Weighing six kilograms it is aimed at doctors' offices, clinics and surgery centres that traditionally forego ultrasound imaging equipment due to space and applicable technology constraints.

The BS-200 is an automatic low-throughput bio-chemistry analyzer designed to replace semi-automatic bio-chemistry analyzers. It is targeted for hospitals and clinics in rural China as well as small hospitals and labs in international markets. It also serves as a backup machine for large hospitals and labs.

"Our growing portfolio of FDA-approved medical devices reflects our commitment to achieving the highest standards in quality and performance and is part of our long-term strategy to compete in the most sophisticated markets in the world," said Mr. Xu Hang, Mindray's chairman and co-chief executive officer.

"Our unique, China-based model leverages world-class R&D that tailors products by functionality and pricing needs for more than 140 countries worldwide. With our established direct sales and service network in the United States and Europe expanded by our recent acquisition, I'm optimistic about our ability to deepen Mindray brand awareness and continue to gain market share."

Mindray recently greatly increased its international business with the acquisition of US company Datascope's patient monitoring business (see Mindray acquires Datascope's patient monitoring business for US$240 million).

To top