Shenzhen based Mindray Medical International Ltd.has received 510(k) clearance from the U.S. Food and Drug Administration for its AS3000 anesthesia delivery system.
AS3000 is designed specifically to penetrate the anesthesia delivery systems market within the U.S., — a market the company estimates will generate approximately USD250 million in 2008. The system provides enhanced inhalation anesthesia and ventilation support capabilities for a variety of anesthesia cases and critical care settings, including hospitals, health clinics, outpatient and ambulatory surgery centers, specialty and surgical hospitals.
"The high quality, competitively priced AS3000 is a testimony of our commitment to leverage a global R&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.
He added 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 company's acquisition of Artema Medical and the recent release of the Spectrum OR anesthesia monitor.