A Medical Device Daily

Masimo (Irvine, California), the maker of pulse CO-oximetry and measure-through motion-and-low-perfusion pulse oximetry, reported FDA clearance for its noninvasive and continuous total hemoglobin monitoring technology (SpHb).

The company said that the availability of Masimo SpHb technology should make hemoglobin measurement more convenient and broadly available to clinicians in both hospital and outpatient settings — helping them make earlier and better clinical decisions, improve patient safety and decrease costs. Noninvasive total hemoglobin will be offered as part of the upgradable Masimo Rainbow SET technology platform.

Ronald Miller, MD, professor and chair of the department of anesthesia and perioperative care at the University of California, San Francisco, said, "Management of appropriate blood levels is vitally important to sustain life. Without up-to-date hemoglobin levels, patient bleeding in the operating room, recovery room, intensive care or trauma departments — where blood loss is common — often can go undetected until it poses critical short and long-term dangers to health and recovery."

He added that the ability to immediately and continuously measure hemoglobin levels "will facilitate the timely administration of appropriate blood products. Conversely, during surgery, because blood is a precious and costly resource, continuously measuring hemoglobin levels noninvasively can help clinicians avoid unnecessary blood transfusions and decrease costs by more effectively titrating blood and blood replacement products."

The Masimo Rainbow SET platform allows clinicians to noninvasively and continuously measure oxygen content (SpOC), carboxyhemoglobin (SpCO), methemoglobin (SpMet, PVI and total hemoglobin (SpHb), in addition to oxyhemoglobin (SpO2), perfusion index (PI) and pulse rate (PR).

Masimo said it anticipates commercial availability for both SpHb and SpOC in 3Q08 to select customers.