Company Announces Update on Product Approval Pipeline
SHENZHEN, China, March 31 /Xinhua-PRNewswire/ -- Mindray Medical International Limited (NYSE: MR) today announced it has received 510(k) clearance from the United States Food and Drug Administration ("FDA") for its portable M5 ultrasound imaging system and BS-200 automatic bio-chemistry analyzer. Mindray has to date received FDA 510(k) clearance for a total of 14 products, covering patient monitoring and life support products, in-vitro diagnostic products and medical imaging systems.
The company also announced it has received approval from the Chinese State Food and Drug Administration ("SFDA") for the M5 and its DC-3 color ultrasound imaging system and provided an update on its product approval pipeline.
"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."
Latest product launches and approvals
In the first quarter of 2008, Mindray's portable M5 ultrasound imaging
system received both FDA and SFDA approval and has been launched in both
domestic and international markets. The M5 is the company's first
laptop-size ultrasound im
|SOURCE Mindray Medical International Limited|
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