Etiometry’s Platform for Clinical Decision Support Software Earns 6th FDA Clearance

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Etiometry News Card

BOSTON, December 2nd, 2020 – Etiometry, the leader in clinical decision-support software for critical care, today announced it has received its 6th 510(k) clearance from the US Food and Drug Administration (FDA) adding several new features to the Etiometry Platform. Included are two significant enhancements to their previously cleared patient risk indices. These upgrades provide flexibility to adjust index thresholds to achieve individualized patient risk assessment based on patient condition and needs. They also provide further insight into the primary physiologic factors that are contributing to a patient’s risk index at a given time. Also included in this recent clearance is Etiometry’s Surveillance View, which provides remote unit-wide viewing of patients on a single display.

“With the new flexibility to accommodate different patient conditions and the increased transparency of our indices, we have a steppingstone into new markets and effective drivers for further clinical utilization that broaden the benefits of the Etiometry Platform.” explained Etiometry’s Chief Technology Officer and Co-founder, Dimitar Baronov.

Last year, Etiometry received FDA clearance for its second ground-breaking patient risk index – the Inadequate Ventilation of Carbon Dioxide (IVCO2) Index™; which joined the Inadequate Delivery of Oxygen (IDO2) Index™ in the company’s growing repertoire of model-based analytics for proactive patient assessment. The platform also includes T3 Data Aggregation & Visualization Software which enables clinicians to review comprehensive trended patient data including key vital sign parameters, lab results, and medical device inputs.

About the Latest Etiometry Platform Enhancements

  • Selectable Risk Index Thresholds – Clinicians can now select a patient-centered threshold for IDO2 and IVCO2 indices that allow for a more meaningful baseline of an individual patient’s complex condition which translates into more personalized, actionable data for the clinician.
  • Measurement Contributions – This feature gives clinicians insights into what values from primary monitoring sources are contributing to elevated patient risk index scores by hovering over a trended risk index within the platform for a more transparent assessment.

“This FDA clearance, spurred by clinician user feedback, illustrates how agile our team is in rapidly iterating software to provide even greater value to our users for faster, more contextual clinical decision support,” said Shane Cooke, Etiometry President and Chief Executive Officer. “These features enable expanded applications in wider patient populations, which is critical as we have entered new market segments such as the NICU and adult ICUs,” added Cooke.

About Etiometry

Etiometry Inc. is the leader in clinical decision-support software for the intensive care environment. Our technologies provide valuable clinical insight and analysis to support early recognition of subtle changes in patient condition to avoid complications and speed recovery. Etiometry is committed to improving patient outcomes, increasing clinical efficiency, and lowering costs of care through the more effective use of all available data.

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