OrSense Ltd. has obtained US Food and Drug Administration (FDA) approval for its NBM-200MP, a non-invasive monitor of oxygen saturation in the blood (oximetry).
Ness Ziona-based OrSense is a medical device that develops monitors for various blood factors, including oxygen saturation, hemoglobin, and glucose levels.
OrSense CEO Lior Ma'ayan said, "Current blood oxygen saturation measurement device, based on natural pulse, are suitable for patients in non-critical condition. The change in pulse affects the blood flow, enabling measurement of oxygen saturation. In our case, even when the natural pulse is weak, or the signal is weak, it's still possible to take a measurement."
Non-invasive pulse oximetry has become a standard of care in operating and recovery rooms, intensive care units, and emergency services, but is liable to provide erroneous oxygen saturation readings in situations of low perfusion, low cardiac output and low blood flow. In the 20% of cases in which patients are in critical condition, current devices do not function properly.
The company says that its system offers non-invasive, continuous and accurate measurement of oxygen saturation in states of hypovolemia, hypothermia, vasoconstriction, and during open heart surgery.
Ma'ayan added, "We are excited about receiving our first FDA approval." He added, "This is a natural development of our business strategy, subsequent to securing our initial clients and third 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 US later this year,"
The NBM-200MP’s performance was validated by multiple center trials in the US and Europe. The studies were desaturation (induced hypoxia) trials and long-term monitoring of patients in intensive care unit patient.
OrSense chairman Dr. Shimon Eckhouse is the founder of Lumenis Ltd. and Syneron Medical Ltd. (Nasdaq: ELOS).
Published by Globes [online], Israel business news - www.globes-online.com - on March 23, 2010
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