Mindray Receives FDA Approval For Two Products Targeting North American Market
Shenzhen, China — Mindray Medical International Limited, a leading developer, manufacturer and marketer of medical devices in China with a rapidly growing international presence, recently announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its BC-3200, an automatic three-part differential hematology analyzer, and Hypervisor VI, a central monitoring system.
"We are optimistic about the international growth potential of these two FDA approved products," said Mr. Xu Hang, Mindray's Chairman and Co-Chief Executive Officer. "Patients and hospitals are closely focused on healthcare costs and as a result we believe that our high-quality and competitively priced products have a strong competitive advantage in the North American market."
The BC-3200 three-part differential hematology analyzer is the first automatic diagnostic laboratory instrument introduced by Mindray targeting the North American market. The BC-3200 is designed to provide reliable, efficient, and safe closed-tube sampling with a throughput rate of up to 60 samples per hour. The device is specifically targeted for cost-sensitive healthcare facilities and small laboratories as it delivers both more accurate test results and better overall performance than comparably priced devices. The Company plans to launch additional diagnostic laboratory instruments such as biochemistry analyzers and a five-part differential automatic hematology analyzer in the North American market in the next 12 to 18 months.
The Hypervisor VI central monitoring system allows hospitals to benefit from powerful networking and patient data review capabilities. The system can connect up to 32 bedside patient monitors and allows healthcare professionals to view and manage data from each connected monitor and the hospital's record system at a central monitoring station. The introduction of the Hypervisor VI in the North American market increases the functionality of three of Mindray's existing patient monitoring devices including the VS-800, PM-8000 Express and PM-9000 Express, which are all compatible with the Hypervisor VI and currently available for sale in the U.S. market.
To date, Mindray has received 510(k) clearance from the FDA for a total of 10 products, covering patient monitoring devices, diagnostic laboratory instruments, and ultrasound imaging systems. The Company expects to begin shipment of the BC-3200 to North America in late June 2007.
About Mindray
Mindray Medical International Limited is a leading developer, manufacturer and marketer of medical devices in China with a significant and growing presence worldwide. Established in 1991, Mindray offers a broad range of products across three primary business segments: patient monitoring devices, diagnostic laboratory instruments, and ultrasound imaging systems. Mindray is headquartered in Shenzhen, China, and has 29 local sales and services offices in China, as well as sales and services offices in Boston, Istanbul, London, Mumbai, Seattle and Vancouver.
SOURCE: Mindray