Mindray Medical International, a developer, manufacturer and marketer of medical devices, has updated its new product launches and product pipeline for domestic and international markets for 2008.
The Shenzhen, China-based company said it plans to release its BC-5300 and BC-5380. Both models are compact five-part hematology analyzers, targeted for mid to high-end hospitals in China and medium-end labs in international markets. The BC-5300 and BC-5380 are expected to receive FDA approval by the end of January and CE Mark in the first quarter 2008, according to Mindray.
The company also said it expects its DC-3 color ultrasound diagnostic imaging system to be launched in China and international markets upon receiving CE Mark and FDA clearance in the first quarter 2008. The DC-3 is designed to have wide applications in abdominal, OB/GYN, endovaginal, cardiac, small parts and pediatric markets.
The company also said it will apply for FDA 510(k) clearance for its Beneview T5, T6, T8, PM-60, BS-200 chemistry analyzers and both its M5 and DC-3 diagnostic ultrasound systems.
Xu Hang, Mindray's chairman and co-CEO, said, the company’s aim is “to release seven to nine” products annually as it proved in 2007.