Etiometry’s Clinical Decision-Support Software Receives CE Mark

News and Press Releases

This marks the latest regulatory approval for Etiometry as the second adult and third pediatric market authorization

October 12, 2022 08:00 AM Eastern Daylight Time

BOSTON–(BUSINESS WIRE)–Etiometry, a leader in clinical decision-support software for critical care, announced today that the company has obtained the CE Mark under the European Union’s medical device regulation, marking the second adult and third pediatric market authorization. Etiometry’s AI-powered clinical decision tool helps clinicians identify subtle signs of deterioration and enable effective care coordination, with published evidence demonstrating decreased length of stay and readmissions.

The certification will allow for the use of the Etiometry platform and algorithms that use models of human physiology to interpret patient data into individualized risk assessments in the European Union (EU) and the United Kingdom (UK). This is the latest regulatory milestone for Etiometry, which has received seven FDA clearances and two Health Canada approvals and opens the door to expansion in Europe for the rapidly growing company.

The Etiometry platform is a web-based software application designed to unleash the power of the vast amounts of patient-generated data in high acuity settings into innovative contextualized visualizations. Consolidating information from disparate applications into easy-to-interpret trends empowers timely clinical decisions that help improve patient outcomes. Clinicians can use data captured by the Etiometry platform for decisions at the bedside, remote intensive care patient management, quality improvement initiatives, and clinical research.

The Etiometry platform is device agnostic and aggregates data and trends information from all clinical devices, including:

  • Vital sign monitors
  • Ventilators
  • Near-infrared spectroscopy monitors
  • Cardiac output monitors
  • Laboratory information systems
  • Electronic health systems

“This recent regulatory approval across Europe allows Etiometry to further expand the footprint of our clinical decision support software into one of the most important markets in the world,” said Shane Cooke, CEO of Etiometry. “We already serve the top pediatric and adult hospitals in the United States and Canada, and now Etiometry can support the top hospitals in Europe. As our business grows and serves new markets, our team continues to focus on new insights and innovations with our AI technology that help clinicians improve patient care and outcomes.”

The most recent innovation from Etiometry in 2022 is the advancement of its patented Risk Analytics Technology with the launch of two new model-based algorithms, bringing the portfolio total to four proprietary indices. Etiometry’s risk indices process the data generated by patients in pediatric and adult critical care settings to bring timely awareness to the patient’s condition and help avoid patient harm.

The Etiometry platform risk indices include:

  1. IDO2 Index™ for inadequate delivery of oxygen,
  2. IVCO2 Index™ for inadequate ventilation of carbon dioxide,
  3. ACD Index™ for acidemia, and
  4. HLA Index™ for hyperlactatemia.

These advancements and market approvals demonstrate the scalability of Etiometry to transform continuously acquired physiologic data into essential insights for clinical decision-making.

About Etiometry

Founded in 2010, Etiometry is a leader in clinical decision-support software designed to help clinicians in the intensive care setting make data-based decisions regarding their patients’ care and treatment. The company’s technologies provide valuable clinical insight and analysis to support early recognition of subtle changes in patients’ conditions to avoid complications and speed recovery. Etiometry has seven FDA clearances, four Health Canada approvals, and the CE Mark. With roots in pediatric ICUs, Etiometry’s software is utilized in the top pediatric and adult hospitals worldwide. Etiometry is committed to improving patient outcomes, increasing clinical efficiency, and lowering the cost of care through the more effective use of data. To learn more, visit


Andrew Young

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