OrSense Receives FDA Clearance for Noninvasive Hemoglobin Monitor

OrSense Ltd., developer of solutions for non-invasive measurements of various blood parameters, has received U.S. Food and Drug Administration clearance for its NBM-200MP, noninvasive hemoglobin (Hb) and pulse oximetry monitor. The NBM-200MP belongs to OrSense’s NBM-200 family of products, for the noninvasive measurement of Hb levels, enabling monitoring of anemia and hemorrhage.

Currently, Hb measurements require collection of blood samples, rendering existing testing methods invasive, painful, time consuming and labor intensive. OrSense’s systems offer a non-invasive solution for accurate Hb measurements and hold the potential for improving anemia detection and monitoring by eliminating pain, reducing infection risk and enabling swift Hb level analysis. In addition, noninvasive Hb monitoring offers the possibility of continuous Hb measurement, which can be critical when monitoring bleeding in acute conditions, such as during surgery or childbirth. The NBM-200 systems are compatible with a variety of clinical environments, including hospitals, outpatient clinics and mobile health, and are used for various applications such as primary care, public screening, women’s health and homecare.

“Hemoglobin levels are a critical parameter in practically every aspect of medical care – in the chronically ill, women’s health, during child development, in the operating room and intensive care wards, and during routine checkups in outpatient clinics. Although over 400 million Hb lab tests are performed annually in the U.S. alone, this important blood test remains costly, time consuming, invasive and intermittent,” said Lior Maayan, OrSense CEO. “Our noninvasive hemoglobin monitor manages both acute and chronic anemia. We are very excited that soon after receiving China FDA approval and in addition to the CE Mark, our hemoglobin and oximetry monitor has now received regulatory recognition in the U.S., which marks the first and important step towards bringing OrSense’s solution to the U.S. market for the benefit of patients in the U.S. and worldwide.”

OrSense’s devices are based on its proprietary SpectOLight technology, which uses an optical measurement platform combined with a ring-shaped sensor that is fitted on the subject’s finger. A gentle pressure is applied by the sensor, temporarily occluding the blood flow in the finger. New blood dynamics are created, generating a unique, strong optical transmission signal, with a high signal-to-noise ratio which is wholly blood specific. 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 subject’s blood constituents.

Anemia is a condition in which there are not enough healthy red blood cells, and therefore not enough Hb to carry adequate oxygen to the tissues. Anemia is diagnosed when Hb levels are lower than normal. This condition affects close to 2 billion people worldwide and is crucial in maternal health, infectious diseases and nutrition. Yet, despite its prevalence, it remains one the most underdiagnosed conditions in community healthcare. Anemia is highly prevalent in the United States, with an estimated 15 percent of young children,10 percent of women and the elderly, up to 75 percent of people undergoing surgery and 90 percent of in-patients suffering from low Hb levels. The long term effects of chronic anemia can be potentially serious, starting from poor development and reaching cardiovascular diseases. In addition, anemia is a key co-morbidity in noncommunicable diseases such as diabetes, cardiovascular diseases, cancer and respiratory conditions, and thus plays a key role in chronic disease management.

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 noninvasive hemoglobin systems are available in 60 countries worldwide.