Masimo has received FDA 510(k) clearance for the Radius-7, the first and only wearable, tetherless, noninvasive rainbow monitor.
Radius-7 connects to Masimo’s Root patient monitoring and connectivity platform and now enables noninvasive monitoring of more than 10 parameters, including, for the first time in a wearable device, total hemoglobin (SpHb), a breakthrough measurement that noninvasively and continuously measures hemoglobin concentration.
SpHb monitoring may provide additional insight to the directional trend of hemoglobin between invasive blood samplings — when the SpHb trend is stable and the clinician may otherwise think hemoglobin is decreasing; when SpHb trend is rising and the clinician may otherwise think hemoglobin is not rising fast enough; or when the SpHb trend is decreasing and the clinician may otherwise think hemoglobin is stable. SpHb may thus help clinicians make more timely and informed decisions, and has been shown to help clinicians provide more timely blood transfusions and reduce blood transfusions in cases such as neurosurgery and orthopedic surgery.
For the first time, it is possible to offer patients freedom of movement while providing such important monitoring, and studies have shown that patient mobility is a key factor in more rapid patient recovery. When monitoring ambulating patients, Radius-7 communicates to Root at the bedside and thereby to Masimo Patient SafetyNet to alert clinicians of critical changes in oxygen saturation, pulse rate, respiration, and hemoglobin, among other parameters.
Radius-7 is lightweight, weighing only 0.34 lbs, and attaches to the arm, thus allowing untethered monitoring whether a patient is in or out of bed – which also reduces the need for nursing assistance, as there is no need to disconnect from or reconnect to a bedside monitor. Each Radius-7 comes with two “hot-swappable” rechargeable battery modules (one with the patient, one charging), each with a battery life of 12 hours, minimizing monitoring interruption.