OrSense, a developer of solutions for non-invasive measurements of various blood parameters, announced that it has received the US Food and Drug Administration clearance for its NBM-200MP, noninvasive hemoglobin (Hb) and pulse oximetry monitor.
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 unique, breakthrough, 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.
OrSense CEO Lior Maayan noted 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. Our noninvasive hemoglobin monitor offers a true revolution in the management of 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," Maayan added.
