FDA approves OrSense's NBM-200MP non-invasive oximetry and low signal oximetry sensor

OrSense Ltd., developer of monitors for non-invasive measurements of various blood parameters, announced today it has received U.S. Food and Drug Administration (FDA) approval for NBM-200MP, a non-invasive oximetry and low signal oximetry sensor.

“Monitoring of oxygen saturation in low perfusion”

Non-invasive pulse oximetry has become a standard of care in the operating and recovery rooms, intensive care units and emergency services, yet it has been known to provide erroneous oxygen saturation readings in situations of low perfusion, low cardiac output and/or low blood flow. OrSense's system offers non-invasive, continuous and accurate measurement of oxygen saturation in states of hypovolemia, hypothermia and vasoconstriction or during open heart surgery, as well as during regular perfusion. The NBM-200MP’s superior performance was validated by multi-center trials in the U.S. and Europe. The studies were comprised of desaturation (induced hypoxia) trials and long-term ICU patient monitoring. The noninvasive results were compared to an arterial "gold standard" reference.

“The ability to accurately measure oxygen saturation in states of low perfusion in acute care patients is critical for intensive care units,” said Prof. Pierre Singer, Head of the Intensive Care Unit at Rabin Medical Center in Petah Tikva, Israel. “OrSense’s non-invasive oximeter could be used for accurate, safe and easy to use oxygen saturation evaluation in various hospital wards. Consequently, it will improve patient care and survival, as well as reduce staff workload,” Prof. Singer concluded.

"We are excited about receiving our first FDA approval. Our device exhibits superior performance, and offers for the first time, a non-invasive, continuous and accurate measurement of oxygen saturation under extreme physiological conditions, including low perfusion and cases of poor signal quality," said Lior Ma'ayan, CEO of OrSense. "This is a natural development of our business strategy, subsequent to securing our initial clients and 3rd party integration agreements in Europe for our non-invasive multi-parameter sensor for hemoglobin and low signal oximetry measurements. We are looking forward to the initiation of commercial efforts in the U.S. later this year," added Ma'ayan.

Shimon Eckhouse, Ph.D., OrSense's Chairman of the board commented, “We are very pleased with the clearance by the FDA in recognition of our proprietary occlusion release technology and extensive investment in product development and clinical work. We view this clearance as the next step in OrSense’s strategy to commercialize its technology for a wide range non-invasive measurement of blood parameters.”

Source OrSense


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