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

2:38 pm by | 1 Comments

EarlySense's EverOn device

EarlySense’s EverOn device

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.

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Stephanie Baum

By Stephanie Baum

Stephanie Baum is the East Coast Innovation Reporter for MedCityNews.com. She enjoys covering healthcare startups across health IT, drug development and medical devices and innovations deployed to improve medical care. She graduated from Franklin & Marshall College in Pennsylvania and has worked across radio, print and video. She's written for The Christian Science Monitor, Dow Jones & Co. and United Business Media.
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Sounds interesting. If it works it would be invaluable in today's overworked, understaffed and under paid nursing staff. Most importantly though, is the benefit of immediate detection and notification of a patient who is decompensating