Mindray Receives US Approval for Two Medical Systems

Jun.15.08 | About: Mindray Medical (MR)

Mindray Medical International Limited (NYSE: MR) announced during the past week that two medical products have received 510(k) clearance for US use from the FDA.

One product, the AS3000 next generation anesthesia delivery system, was developed by Mindray’s recent acquisition, Datascope Patient Monitoring. The AS3000 delivers precision anesthesia and ventilation assistance in a product aimed at ambulatory surgery centers and community hospitals in the US. Mindray expects the AS3000 will produce $250 million in revenues during 2008. The unit is designed to be integrated with DPM’s monitors and other patient systems. According to Mindray, the AS3000 is priced “competitively.”

With the AS3000, Mindray is broadening its assault on the perioperative (pre-, intra- and post-operative) market. This initiative was also aided by the acquisition of Artema Medical and the recent release of the Spectrum OR anesthesia monitor. Mindray completed its acquisition of New Jersey-based Datascope Monitoring in May 2008.

Mindray’s other recently approved product adds a product in the lower price range of its ultrasound line: the DC-3 color ultrasound imaging system. This product was previously cleared by the SFDA and given the CE Mark for use in Europe.

Mindray said the DC-3, which combines 2D imaging and color Doppler, offers a “superior price-to-performance” ratio. The DC-3 is aimed at expanding Mindray's customer base in low-end markets, while the DC-6 and portable M5 ultrasound imaging systems target their middle and high-end customers. The DC-6 received FDA 510(k) clearance in September 2006, and the portable M5 was approved in March 2008. In total, Mindray offers over 10 medical imaging products, five of which have been approved for use in the US.

So far, Mindray has received FDA 510(k) clearance for a total of 16 products, including patient monitoring and life support products, in-vitro diagnostic products and medical imaging systems. DPM has received FDA 510(k) clearance for 9 products.

Disclosure: none.