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New anaesthesia delivery system receives 510(k) clearance from US FDA

Mindray Medical International : 13 June, 2008  (New Product)
Mindray Medical International has received 510(k) clearance from the US Food and Drug Administration for its AS3000 next generation anaesthesia delivery system developed by Datascope Patient Monitoring, a Mindray company.
'We're optimistic about the addition of this powerful anesthesia workstation to our growing portfolio of FDA approved medical devices and comprehensive suite of product offerings,' said David Gibson, DPM's president. 'The AS3000 enables us to expand our base of physiologic monitoring throughout the peri-operative environment, increase our market share in the anesthesia delivery systems market and further strengthen our leading position in ambulatory surgery centers and community hospitals.'

The AS3000 delivers precision anaesthesia and ventilation assistance with an intuitive design developed to bring a higher level of ergonomics to the operating room. The AS3000 is designed specifically to penetrate the anaesthesia delivery systems market within the US, which is a market that the company estimates will generate approximately $250 million in 2008. The system provides enhanced inhalation anaesthesia and ventilation support capabilities for a variety of anaesthesia cases and critical care settings, including hospitals, health clinics, outpatient and ambulatory surgery centres, specialty and surgical hospitals. The new system can be easily integrated with existing DPM monitors including the recently launched Spectrum OR and Gas Module III and will notably expand market coverage of the DPM Anesthesia product range.

'The high quality, competitively priced AS3000 is a testimony of our commitment to leverage a global R and D platform in order to tailor products by functionality and price and move up the value chain,' said Xu Hang, Mindray's chairman and co-chief executive officer. 'We're encouraged by this approval, the combined efforts of our world-class China-based and DPM engineering teams and the future potential of this complementary fit of assets.'

Mindray noted that this FDA clearance is part of the company's strategic focus to gain market share within the peri-operative markets which has been strengthened by the acquisition of Artema Medical and the recent release of the Spectrum OR anaesthesia monitor.

Mindray has to date received FDA 510(k) clearance for a total of 16 products, covering patient monitoring and life support products, in-vitro diagnostic products and medical imaging systems; DPM has to date received FDA 510(k) clearance for a total of nine products.
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