Mar 23 2010
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