Monitor from EarlySense Approved
The ES-16 monitoring system manufactured by EarlySense, Limited received marketing approval from the Food and Drug Administration. The system is designed to monitor both respiratory and heart rates in the pediatric and adult population without requiring ongoing direct contact with the patient. News of the marketing clearance was published by Forbes.
The ES-16 system uses a contact-free sensor which is proprietary property of the company. The distant monitor generally placed under a patient’s mattress. The sensor includes a single plate with multi-technology mechanical sensors and a device control unit. The controller has integrated signal intake sampling, various modalities for alert output, and signal display and processing.
The EarlSense monitor can be placed either between a mattress and pad or beneath the mattress entirely. The monitor is automatically activated when a patient gets into the bed. The level of monitoring accuracy is on par with the current gold standards required for physiological monitoring.
This sensor design allows for ongoing monitoring of patients while in the hospital, an outpatient clinic, long-term care facility, or at home. In addition, it minimizes patient discomfort while they are being monitoring because direct contact is not required.
Current trials funded by EarlySense are underway to assess use of the device in patients with chronic health conditions such as chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), and asthma. It is also being assessed for use among patients who are in critical care settings and those who have undergone surgery.
Dr. Danny Lange and Mr. Avner Halperin are the founders of Early Sense, which started operations in 2004. The company is based in Israel. Mr. Avner serves as the Chief Executive Officer of the organization.
November 30, 2007 Related topics: Product Approval & Certification, Quality, Safety, Errors