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Masimo SpHb device gets Japanese clearance

Masimo has received the Japanese Ministry of Health, Labor and Welfare (MHLW) regulatory clearance for its noninvasive and continuous hemoglobin (SpHb) measurement device, available as part of the Masimo rainbow SET platform.

SpHb noninvasively and continuously measures a patient’s hemoglobin levels without needles, time-consuming laboratory analysis, and risk of contamination associated with traditional blood tests.

Masimo said that SpHb help clinicians to determine patient’s low hemoglobin level and facilitate detection of internal bleeding and appropriate administration of blood transfusions, that is continuously displayed on Masimo rainbow SET Pulse CO-Oximeters.

Masimo founder and CEO Joe Kiani said that receiving full MHLW regulatory approvals for SpHb makes the noninvasive, continuous measurement of hemoglobin universally available to Japanese clinicians.

“This arms clinicians throughout Japan with the real-time assessment of hemoglobin enabling more appropriate management of patients both inside and outside of the operating room,” Kiani said.