Mindray nets FDA clearance for portable ultrasound

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Mindray Medical International has received 510(k) clearance from the FDA for its portable M5 ultrasound imaging system and BS-200 automatic bio-chemistry analyzer.

The Shenzhen, China-based company also announced it has received approval from the Chinese State Food and Drug Administration (SFDA) for the M5 and its DC-3 color ultrasound imaging system and provided an update on its product approval pipeline.

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 anesthesia machines in the second quarter of 2008.