Devices

Etiometry Gains Expanded Clearance for Oxygen Patient Monitor

FDA has cleared an Etiometry 510(k) for the Inadequate Oxygen Delivery (IDO2) Index for monitoring intensive care unit (ICU) patients aged 12 years or younger. Originally cleared by the agency in 2016 for tracking the clinical risk of inadequate oxygen delivery to neonatal patients, the new clearance now allows hospitals to use the IDO2 Index for older patients.

“With the IDO2 algorithm and the Etiometry Platform, doctors and nurses can quickly assess the risk of inadequate oxygen delivery alongside traditional measures of the patient’s status in a manner that clearly visualizes the patient’s trajectory,” the company says. “This solution can be deployed in the ICU and accessed by critical-care providers using a Web-based user interface within the hospital’s network.”

The device continuously assesses 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,” the company says. “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 & Visualization software.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome