US-based EarlySense has received an approval from the US Food and Drug Administration (FDA) for EarlySense 2.0 system, a newly designed bedside monitor for continuous measurement of respiration rate, heart rate and motion, in an automatic and contact-free manner.
EarlySense Clinical and Regulatory Affairs vice president Dalia Argaman noted the newly designed bedside monitor is in line with the company’s constant focus on innovation and patient care improvements.
"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," Argaman added.
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.
For example, 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.
The company’s flagship product, the EarlySense System, is a continuous, contact-free, patient safety monitoring solution that monitors and documents a patient’s vital signs and movement using a sensor that is placed underneath a bed mattress.
There are no leads or cuffs to connect to the patient who has complete freedom of movement and is not burdened by any cumbersome attachments.
The system was designed to monitor patients on medical surgical floors who are usually monitored by nursing staff approximately once every four hours. The system is currently installed at hospitals and rehabilitation centers in the US and Europe.
It is also commercially available in Canada. Hospital administrators report that patients, their families and staff feel more comfortable knowing the system is in place.