Mindray receives US clearance for portable ultrasound system and
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
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).