8 Jan 2014

EarlySense gets FDA device approval for patient monitor update with benchmarking tool

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Medical device maker EarlySense has received a green light for an updated version of its FDA-approved patient monitoring device. The tool uses a pad-sized sensor that fits under the mattress to transmit data on respiration and heart rate as well as movement to a bedside monitor and a monitor at a nurse station. The updated version — EarlySense 2.0 — adds a benchmarking tool to track and analyze hospital staff’s performance to prevent falls and pressure ulcers.

The benchmark analysis reports are provided by EarlySense as part of the clinical implementation process.

The system was initially designed to monitor non-ICU, lower risk patients on medical surgical floors who are usually monitored by nursing staff approximately once every four hours, according to the company’s website. The Israeli company’s U.S. headquarters are in Waltham, Mass. In 2012, the company received regulatory approval to add an oxymetry tool for patients coming out of surgery who require a higher level of supervision.


The patient monitoring system also responds to the alarm fatigue hazard that can accompany some devices by alerting nurses about changes in a patient’s heart rate only when those changes have exceeded a certain threshold.

Tim O’Malley, EarlySense president, has said the company has seen a surge in interest in its devices since the roll out of the Affordable Care Act as a way to reduce risks such as falls and pressure ulcers that can ramp up hospitalization costs.