Etiometry Receives FDA Clearance for AI-Based Algorithm Detecting Hypercapnia Risk in Neonatal Critical Care
Wednesday, August 02, 2023
Etiometry, a prominent clinical decision-support software company, has announced that the Food and Drug Administration (FDA) has cleared its IVCO2 Index™ for usage with neonatal ICU patients weighing less than 2kg, who are at higher risk of hypercapnia effects. This recent clearance marks Etiometry's 9th FDA approval and its second this year.
The IVCO2 Index™ represents a groundbreaking advancement in critical care as it seamlessly integrates data from multiple sources to provide personalized assessments for ventilation-perfusion mismatch and predict the likelihood of a patient having a PaCO2 level exceeding 50 mmHg while under mechanical ventilation. Unlike conventional monitoring methods like arterial blood gas testing and transcutaneous monitoring, which can be challenging for tiny premature newborns, this algorithm was specifically designed to overcome these limitations.
Dimitar Baronov, the Chief Technology Officer of Etiometry, highlighted the IVCO2 Index™ as a unique algorithm that can identify hypercapnia risk without the need for additional hardware attached to fragile patients, enabling clinicians to prioritize care for those who need it most. Given that many NICU patients require ventilatory support and their conditions can change rapidly, vigilant monitoring for hypercapnia becomes essential for maximizing neurodevelopmental outcomes and preventing complications. The digital monitoring offered by the IVCO2 Index™ adds an extra layer of protection between routine blood gas testing, reducing the risk of oversights that could lead to unfavorable outcomes.