EarlySense, the market leader in Proactive Patient Care Solutions, announced today that the company has received FDA Clearance 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.
Background
A new company to our pages, EarlySense has brought to market an innovative technology designed to advance proactive patient care and empower clinicians to achieve claimed better patient outcomes. Through early detection, the EarlySense system assists clinicians in identifying and preventing potential adverse events. It does so by providing motion rates and bed exit alarms, to help reduce falls and pressure ulcers, as well as surveillance of heart and respiratory rates to potentially detect patient deterioration.
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. By adding new monitoring functions the company claims its system delivers a new level of patient care, no doubt adding to the level of comfort experienced by patients, families and staff from the knowledge that such a system is in place.
EarlySense says it 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.
Company comments
“The newly designed Bedside Monitor is in line with EarlySense’s constant focus on innovation and patient care improvements.” said Dalia Argaman, VP of Clinical and Regulatory Affairs at EarlySense. “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.”
Mr. Avner Halperin, CEO of EarlySense added, “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. 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.”
Availability
The EarlySense system is currently installed at hospitals and rehabilitation centers in the USA and Europe. It is also commercially available in Canada.
Source: EarlySense, PR Newswire
published: January 8, 2014 in: Approval/Clearance, Monitoring