Etiometry Receives FDA 510(k) Clearance for its T3 Monitor

Marks significant milestone in development of predictive analytics for patient care

BOSTON–(BUSINESS WIRE)–March 18, 2015–

Etiometry, a pioneering developer of software to improve patient outcomes and reduce the cost of care in intensive care units (ICU), has received FDA 510(k) clearance for its T3 Monitor™ product.

The T3 Monitor is a software-only solution which aggregates data from multiple sources including bedside patient monitors and devices. The current and historical data streams are displayed by the T3 Monitor through a web browser interface to assist clinicians with identifying actionable information and making treatment decisions. The T3 Monitor software is the result of a multi-year collaboration with clinicians from two of the world’s leading research hospitals.

The T3 Monitor is the foundation for Etiometry’s advanced predictive analytics software, the Etiometry Risk Analytics Engine™. 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 Sandbox™. The Quality Improvement (QI) Sandbox software allows clinicians without data analysis expertise to perform off-line analysis of data collected by the T3 Monitor as well as access a multi-institution shared database for creating best-practice protocols.

“FDA approval of the T3 Monitor marks a major milestone in Etiometry’s development of the next generation clinical decision support system. The T3 Monitor in concert with the Etiometry Risk Analytics Engine and QI Sandbox software comprise an end-to-end, scalable platform that will revolutionize patient care and reaffirm Etiometry’s position as the leader in ICU predictive analytics,” said Evan Butler, CEO.

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 predictive analytics solutions for clinical use requires high quality software that has achieved FDA clearance. FDA 510(k) clearance of the T3 Monitor 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 is the leader in continuous, patient-specific analytics to improve care in the ICU. Etiometry’s technology enables clinicians to better comprehend and manage the dynamic condition of ICU patients by providing continuous monitoring of clinical risks and their etiologies which cause harms.

Etiometry
Gary Gallant, 857-366-9333x 2011
VP, Research Collaboration
ggallant@etiometry.com