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Ornim's blood flow monitor cleared by FDA

This article was originally published in Clinica

Executive Summary

Ornim's CerOx 3210F monitor has received 510(k) clearance from the US FDA for a new indication: noninvasive monitoring of tissue blood flow in adults. Previously, it was cleared for noninvasive monitoring of regional haemoglobin oxygen saturation in the brain or skeletal muscle. The device is used in settings including critical care, trauma units, operating rooms and emergency response vehicles. It comprises a stand-alone bedside unit and two sensors that are placed on the skin using an adhesive pad. These employ the firm's patented UTLight technology to measure oxygen saturation using the colour of blood, and blood flow using the phase of light. The oximetry monitoring market is growing by 20% per year, Santa Clarita, California-based Ornim estimates. CerOx 3210F is already CE marked for sale in Europe.

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