T3 Software Receives FDA 510(k) Clearance
News and Press Releases
Marks significant milestone in development of dynamic analytics for patient care
BOSTON, March 17th, 2015 — Etiometry, a pioneering developer of software to improve patient outcomes and reduce the cost of care in intensive care units, has received FDA 510(k) clearance for its T3 Software product.
T3 is a software-based solution which aggregates data from multiple sources including bedside patient monitors and devices. The current and historical data streams are displayed by the T3 Software through a web browser interface to assist clinicians with identifying actionable information and making treatment decisions. The T3 Software is the result of a multi-year collaboration with clinicians from two of the world’s leading research hospitals.
The T3 Software is the foundation for Etiometry’s advanced analytics software, the Etiometry Risk Analytics Engine (RAE). Currently under development, the Risk Analytics Engine will enable early warning of a patient’s deteriorating condition while providing actionable insight into its causes by applying systems engineering algorithms that have been proven in industries such as aerospace and defense. Several world-renowned research hospitals are actively collaborating with Etiometry to develop the system for clinical deployment with the aims of improving ICU patient care outcomes and quality, while reducing its cost.
To accelerate the translation of clinical quality improvement research to bedside application, Etiometry has also created the Quality Improvement System. The Quality Improvement System (QIS) allows clinicians without data analysis expertise to perform off-line analysis of data collected by the T3 Software as well as access a multi-institution shared database for creating best-practice protocols.
“FDA clearance of the T3 Software marks a major milestone in Etiometry’s development of the next generation clinical decision-support system. The T3 Software in concert with the Risk Analytics Engine and Quality Improvement System comprise an end-to-end, scalable platform that will revolutionize patient care and reaffirm Etiometry’s position as the leader in ICU dynamic analytics,” said Evan Butler, COO.
FDA 510(k) clearance applies to Class II medical devices designed for clinical use and imposes more stringent quality requirements than Class I MDDS products, which can only be used to display data retrospectively. “The adoption of dynamic analytics solutions for clinical use requires high quality software that has achieved FDA clearance. FDA 510(k) clearance of the T3 Software paves the way for the delivery of near real-time, continuous, patient-specific analytics to the care team,” said Dimitar Baronov PhD, CTO.
Etiometry is currently expanding its roster of collaborating hospitals for development and evaluation of its Risk Analytics Engine technology.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.
For more information, visit www.etiometry.com.
We’d love to hear from you
Whether you’re curious about how Etiometry can help support your team, the platform’s latest outcomes data or a demo – we’re ready to answer your questions.
Contact UsRelated
The Documentation Gap Nobody Talks About — And What It’s Costing Your ICU
Every ICU has a documentation problem. Most don’t know the full scope of it. Clinical events happen continuously in high-acuity care — hemodynamic shifts, ventilatory changes, transient complications that resolve before the next chart entry. Clinicians respond to them. They manage through them. And then, in the relentless pace of the ICU, those events may […]
Beyond Escalation: How Clinical Intelligence Supports ICU De-Escalation Decisions
In high-acuity care, clinical attention naturally gravitates toward escalation: adding interventions, increasing support, responding to deterioration. But the other half of intensive care, knowing when and how to safely step back from those interventions, is equally demanding and equally consequential. Prolonged mechanical ventilation, extended vasoactive support, mechanical circulatory support (MCS) and delayed discharge carry real […]
Cardiogenic Shock in Cardiac Surgery Patients: Why Continuous Physiologic Data Matters
Cardiac surgery patients don’t come from a single mold. A valve repair patient, a transplant recipient, a CABG patient, and a patient recovering from aortic surgery each carry a different hemodynamic profile and a different trajectory through the ICU. What they share is vulnerability, particularly to one of the most dangerous complications in post-surgical critical […]