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Medical Devices / Submissions and Approvals

Etiometry Acquires FDA Clearance to Expand the Indications IDO2 Index Powered by Risk Analytics

June 14, 2017
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Etiometry has received FDA clearance for its Inadequate Oxygen Delivery (IDO2) index for monitoring ICU patients 12 years or younger.

The index device continuously assesses the patient-specific risk of inadequate oxygen delivery by computing an IDO2 Index that reflects the likelihood that a critically ill child is experiencing this harmful physiologic state.

An increasing IDO2 value means there is an increasing risk of inadequate oxygen delivery and attention should be brought to the patient. The IDO2 Index is computed based on multiple physiologic measures and laboratory results collected by Etiometry’s T3 data aggregation and visualization software.

The device was initially cleared by the FDA in 2016 for tracking the clinical risk of inadequate oxygen delivery to neonatal patients. — Cynthia Jessup

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