FDA clears EarlySense bedside monitor

Launched first in the U.S., monitor will also be available in Europe and Asia
By Bernie Monegain
03:01 AM

EarlySense, which develops and markets patient care solutions, has received FDA clearance for its EarlySense 2.0 System, a bedside monitor for continuous measurement of respiration rate, heart rate and motion, in an automatic and contact-free manner.

“The newly designed bedside monitor is in line with EarlySense’s constant focus on innovation and patient care improvements.” Dalia Argaman, vice president of clinical and regulatory affairs at the Waltham, Mass.-based company, said in a news release. “We provide the clinical team access to actionable information and empower them to identify potentially critical situations and respond in a proactive manner, in the hopes of preventing an adverse event from occurring as well as assisting the clinical team to become more efficient,” she added.

[See also: Newton-Wellesley deploys sensors.]

The newly designed bedside monitor launched in the United States, will soon be launched in Asia and Europe as well, Argaman said.

EarlySense is also enhancing its focus on quality assurance tools and benchmark analysis reports to provide sophisticated management tools that will allow hospital leaders to set quality goals, measure their results, drive staff behavior towards improvement and achieve their objectives.

As example, Early Sense executives say that providing the capabilities to measure staff response times to bed exit alerts, and then reviewing reports with staff has allowed several institutions to improve their response times, and thus reduce fall rates.

[See also: Welch Allyn and EarlySense Announce Strategic Collaboration.]

“EarlySense plans to present a new product line to the market in the first quarter of 2014 that will address hospitals’ needs for better patient supervision,” company CEO Avner Halperin, said in a statement. “The new product line will include safety focused product, addressing falls and pressure ulcers prevention, as well as EarlySense respiratory and heart rate monitoring capability for early detection of patient deterioration.”

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