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News

Mindray receives 510(k) clearance for new ultrasound imaging system

Mindray Medical International : 01 April, 2008  (New Product)
Mindray Medical International has received 510(k) clearance from the US Food and Drug Administration for the company’s portable M5 ultrasound imaging system and BS-200 automatic bio-chemistry analyser.
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 colour 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 Xu Hang, Mindray's chairman and co-chief executive officer. 'Our unique, China-based model leverages world-class R and 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.'

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 imaging device, weighing only six kilograms and combining colour imaging with uncompromised 2D performance. Hand Carried Ultrasound (HCU) is one of the fastest growing Ultrasound segments in the United States and in international markets. The M5 is ideally suited for doctors' offices, clinics and surgery centres that traditionally forego Ultrasound imaging equipment due to space and applicable technology constraints.

The company's BS-200 automatic bio-chemistry analyser also received FDA clearance in the first quarter of 2008 and is available in domestic and international markets. The BS-200 is an automatic low-throughput bio-chemistry analyser designed to replace semi-automatic bio-chemistry analysers. It is targeted for hospitals and clinics in rural China as well as small hospitals and labs in international markets. The instrument also serves as a backup machine for large hospitals and labs.

The DC-3 Ultrasound imaging system, designed to have wide applications in abdominal, OB/GYN, endovaginal, cardiac, small parts and paediatric markets, received SFDA approval in the first quarter of 2008. The product is ideally suited for hospitals and clinics seeking to replace black and white Ultrasound imaging systems.

During the fourth quarter of 2007, the company submitted applications for FDA approval for three of its BeneView series products, including the T5, T6 and T8 multi-parameter patient monitoring devices.

The company expects to receive SFDA approval for its EX55 and EX65 compact anaesthesia machines in the second quarter of 2008.
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