Masimo received FDA clearance and CE Mark of approval for the Radical-7 non-invasive pulse oximeter with rainbow Acoustic Monitoring technology that provides continuous readings of the acoustic respiration rate (RRa) waveform and measurements.
A new feature on the system, not yet approved by the FDA, called In Vivo Adjustment, allows clinicians to calibrate the device to individual patients and to readings from reference quality invasive blood analysis devices.
From the announcement:
The new Radical-7 provides clinicians with the option to measure RRa and display the acoustic waveform directly on the monitor screen with the pleth waveform overlayed—allowing them to observe changes in breathing upon inhalation and exhalation. With this new display capability, clinicians may be able to more readily detect respiratory pause events where there is an absence of breathing, high ambient noise that can degrade the acoustic signal, and improper sensor placement.
The measurement of blood components such as oxygen saturation, methemoglobin, carboxyhemoglobin, and total hemoglobin have inherent and expected variability within and between noninvasive and invasive measurement techniques and from patient to patient. For example, all of the noninvasive measurements use a technique coined ‘patient calibration’ which takes the noninvasive monitor’s detected light that is transmitted or reflected from the patient at different values and matches them to empirically gathered invasive blood measurements from a small number of volunteers and in some cases patients. However, individuals may vary from the pool of patients used in the ‘patient calibration’ and hence provide a bias for the particular patient. In addition, many clinicians are unaware that laboratory reference devices that measure oxygen saturation or hemoglobin can have great variability from each other. In fact, hemoglobin can vary 2 g/dL or more from one manufacturer’s product to another. And, physiologic factors such as the blood source (venous or arterial), site and time of blood draws, blood draw technique, and patient body position are recognized in the clinical literature to add variability to hemoglobin levels. As a result, noninvasive and invasive measurements can vary in the same patient depending on the methods and invasive equipment used.
The In Vivo Adjustment feature available in the new Radical-7 now provides the option to adjust the noninvasive oxygen saturation (SpO2), total hemoglobin (SpHb®), carboxyhemoglobin (SpCO®), and methemoglobin (SpMet®) values displayed on the monitor to the laboratory reference value used at the site by patient. With this new feature, clinicians can adjust the noninvasive value at the beginning of a monitoring period to account for individual patient variation and the laboratory reference value and continuously trend the noninvasive value to the patient and reference laboratory value until the next blood sample and laboratory analysis.
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