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Masimo's continuous haemoglobin monitoring tech approved in Japan

This article was originally published in Clinica

Executive Summary

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Masimo's noninvasive, continuous haemoglobin (SpHb) monitoring technology. SpHb is available as part of the firm's Masimo Rainbow SET platform. Haemoglobin monitoring is used in various settings including detecting internal bleeding and anaemia. Irvine, California-based Masimo claims that its device avoids the drawbacks associated with traditional blood testing for haemoglobin, such as the use of needles and the delay when sending the sample to the lab for analysis. The technology received US FDA 510(k) clearance in May 2008 (www.clinica.co.uk, 23 May 2008), and Masimo launched it in "most other countries" in March 2009 (www.clinica.co.uk, 25 March 2009).

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