Etiometry gains FDA clearance of AI-based algorithm for neonates in critical care

Etiometry, a leading provider of clinical decision-support software, has achieved a significant milestone with its IVCO2 Index receiving clearance from the Food and Drug Administration for use in neonatal ICU patients weighing under 2kg. These delicate patients are particularly susceptible to the effects of hypercapnia, a condition characterised by elevated levels of carbon dioxide in the blood. This FDA clearance marks Etiometry's 9th regulatory approval and its second this year.

The IVCO2 Index is a revolutionary tool in critical care, leveraging multiple data sources to offer personalised assessments of ventilation-perfusion mismatch and predict the likelihood of a patient having a PaCO2 (partial pressure of carbon dioxide) of greater than 50 mmHg in mechanically ventilated individuals. Designed to address the limitations of traditional monitoring methods, such as arterial blood gas testing and transcutaneous monitoring, the IVCO2 Index eliminates the need for additional hardware, particularly in the case of tiny premature newborns.

Dimitar Baronov, CTO of Etiometry, describes the IVCO2 Index as a groundbreaking algorithm that enhances the ability to detect hypercapnia risk without putting additional stress on the fragile patients. This non-invasive approach allows clinicians to prioritise care for those who require it the most.

Vigilant monitoring for hypercapnia is crucial in the neonatal ICU setting, where many patients rely on ventilatory support and can experience rapid changes in their condition. By continuously and accurately monitoring for hypercapnia, Etiometry's technology helps maximise neurodevelopmental outcomes and prevent potential complications. The digital monitoring system provides real-time insights into the patient's condition between routine blood gas testing, adding an extra layer of protection to prevent oversights and improve overall outcomes.

Shane Cooke, CEO of Etiometry, believes that the IVCO2 Index will extend the improved outcomes already achieved by Etiometry's partners in cardiac ICUs and PICUs into the NICU environment.

Etiometry plans to showcase its risk indices and platform's capabilities for enhancing decision-making at the upcoming World Congress of Pediatric Cardiology and Cardiac Surgery in Washington, D.C. The company has also submitted five abstracts to support discussions and advancements in the field.

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