Orsens, a company for the development and marketing of devices for the non-invasive measurement of the various blood components, announced today that it received approval from the US Food and Drug Administration (FDA) for the NBM-200MP, a device for non-invasive measurement of blood oxygen saturation, both in a normal state and in a state where a signal is received extremely low. Until today, it was not possible to accurately measure the level of oxygen in the blood without a puncture in these extreme situations.
Non-invasive measurement of blood oxygen saturation has become the accepted measurement in operating and recovery rooms, intensive care units and emergency medical services. However, in certain situations where the blood supply to the extremities of the body is low, such as when the cardiac output is low or the blood flow is weak, the existing devices will provide incorrect measurement results. The existing devices do not function properly in 20% of patients who are in a critical condition, for whom the measurement is the most important.
The NBM-200MP measurement system enables continuous and accurate measurement of the oxygen saturation in the blood not only when the blood supply is normal but also in situations of lack of blood, hypothermia, vasoconstriction or during heart surgery, all in a non-invasive manner. The superior performance of NBM-200MP has been demonstrated in multicenter clinical trials in Europe and the USA. The tests included measurements under conditions of low levels of oxygen saturation in the blood (hypoxia) as well as long-term monitoring of patients hospitalized in the intensive care unit. The non-invasive results were compared to a standard of arterial measurements1. The performance of Orsense's device has proven to be significantly better than the best systems on the market today.
"The ability to accurately measure the blood oxygen saturation in critically ill patients, who have weak blood circulation, is an essential need in intensive care units," said Professor Pierre Singer, head of the general intensive care unit at the Rabin Medical Center in Petach Tikva. "The non-invasive measurement device of Orsense can be used for accurate, safe and convenient measurement of oxygen saturation in a variety of hospital departments. Because of this, it will improve the level of treatment and the survival of patients, and also make the work of the medical staff easier," Professor Singer concluded.
"We are happy and excited about our first FDA approval. The performance of our device is significantly better than those that exist today, and we offer, for the first time, a non-invasive, continuous and accurate measurement of oxygen saturation even in extreme physiological conditions such as during weak blood flow and in cases of a weak and poor quality signal," said Lior Mein, CEO of Orsens .
"This is a natural development of our business strategy, after we signed first deals and distribution agreements in Europe for the multi-parameter non-invasive measuring device for measuring hemoglobin level and oxygen saturation. We are preparing to start marketing activities in the US later this year," Mein added.
Dr. Shimon Ekhuiz, chairman of Orsense, stated, "We are very pleased with the FDA's approval and the recognition of Orsense's unique technology, and the extensive investment in product development and the clinical trials we conducted. We see this approval as the next step in Orsens' strategy towards commercializing our technology for the non-invasive measurement of a wide range of blood parameters."
About NBM-200MP
The NBM-200MP continuously and non-invasively measures a variety of blood parameters, including hemoglobin oxygen saturation and oxygen saturation under conditions of weak blood flow. The system works with the help of a ring-like sensor that is adapted to the subject's finger and applies gentle pressure that causes a temporary blockage of blood flow.
During the blockage, optical components in the sensor perform a sensitive measurement of light rays passing through the finger, and provide information on the various blood components in a quick, accurate and painless manner. The device significantly improves the comfort of the subjects, prevents infections that may occur in invasive tests, and provides doctors with more immediate and accurate results than those available today.
About Orsense
Orsens is a medical device company that develops non-invasive measurement systems for monitoring the level of oxygen saturation and hemoglobin in the blood, the blood sugar level and other parameters. NBM-200MP, which was approved by the FDA, is a non-invasive device intended for use in hospitals for measuring the level of oxygen in the blood. The device for non-invasive measurement of the level of hemoglobin in the blood received CE approval and was tested on more than 8,000 patients and donors at 20 sites in the USA and Europe. The company's products are based on a unique optical technology that overcomes difficulties that limit competing approaches. The device that Orsens is developing for non-invasive measurement of sugar has also received CE approval, tested on more than 450 diabetic patients with performance similar to that of invasive devices for measuring sugar. Israel Health Care Ventures and STAR are among the venture capital funds invested in the company.
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Comments:
1 Weinstein et al. "Monitoring of oxygen saturation in low perfusion"
European Journal of Anaesthesiology, S. 45, pg. 42, 2009
One response
what?!?
A non-invasive device for measuring saturation (which works on invisible light) has been around for years... I didn't understand the big innovation here...