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OrSense Non Invasive Hemoglobin Monitor Received CFDA Approval for Marketing in ChinaOct. 28, 2013
- The device will be launched at the China International Medical Equipment Fair -
Petach Tikva, Israel, October 28, 2013 – OrSense Ltd., developer of monitors for non-invasive measurements of various blood parameters, today announced that it has received China Food and Drug Administration approval for NBM-200, its non-invasive hemoglobin (Hb) system for anemia monitoring and hemorrhage detection. The device will be launched in China at The 70th China International Medical Equipment Fair that will take place on Nov. 3-6, 2013 in Siming District, Xiamen, Fujian, China.
Lior Maayan, CEO of OrSense said, "We are very excited that NBM-200, our non-invasive hemoglobin device, has been officially certified by the China Food and Drug Administration. The World Health Organization estimates that over 200 million people in China suffer from anemia. China, with its healthcare reform and focus on primary care and prevention, represents a significant growth opportunity for our innovative platform. We believe that NBM-200 will be a welcome addition in hospitals, clinics, public health programs, blood donation centers and nutrition programs throughout China, due to its ease of use and safety profile, helping improve health in China as well as around the globe."
Hemoglobin (Hb) measurements allow the detection of anemia and hemorrhage, and are widely used by hospital wards such as operating rooms, ICU, emergency and delivery rooms as well as in outpatient clinics and women and children healthcare facilities. In blood donation centers, a pre-donation Hb measurement is required from blood donors to protect anemic donors and to ensure adequate Hb content of blood units. Currently determination of Hb levels is usually performed using capillary blood obtained by finger pricking, rendering current Hb screening methods invasive, painful, time consuming and labor intensive.
Non-invasive measurement of Hb has many advantages, including the prevention of pain and potential transmission of infectious diseases and the reduced need for trained personnel. NBM-200 offers a unique, breakthrough, non-invasive solution for accurate and quick Hb measurements. Multiple trials, published reports, and registries of patients diagnosed with the NBM-200 device consistently demonstrate accurate measurements combined with a positive safety profile, reduction of infection risk and a greatly improved donor and patient comfort.
OrSense's portable non-invasive device or the measurement of Hb and oximetry operates via a ring-shaped sensor that is fitted on the person's finger and applies pressure, temporarily occluding local blood flow. During the occlusion, optical elements in the sensor perform a sensitive measurement of the light transmitted through the finger. This method, called Occlusion Spectroscopy, provides a quick, accurate and painless measurement of the donor's and patient's blood constituents.
OrSense is a medical device company developing and marketing non-invasive monitoring systems for measurements of hemoglobin, oxygen saturation, glucose and other blood parameters. OrSense’s CE approved non-invasive hemoglobin monitor is available in 55 countries world-wide, and has been successfully installed in multiple environments including hospitals, physician offices, blood donation facilities, as well as used for various applications including public screening, women health and homecare. In addition, the Company's FDA cleared NBM 200MP is a non-invasive blood oximetry monitor for use in hospitals. OrSense's products are based on its proprietary Occlusion Spectroscopy technology, which overcomes key obstacles that hinder the performance of competing approaches. For additional information, please visit OrSense’s website at www.orsense.com.
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