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Medical Devices / Regulatory Affairs / Submissions and Approvals

FDA Clears EarlySense Bedside Monitor

Jan. 10, 2014

The FDA has granted 510(k) clearance for Israel devicemaker EarlySense to market an updated version of its EarlySense bedside monitoring system, the company announced Wednesday.

Originally released for sale in the U.S. in 2010, the newer 2.0 system adds unique adaptation to patient needs, immediate notification to nursing staff and reporting capabilities with response time tracking to help prevent patient falls. EarlySense 2.0 also alerts staff within 50 seconds of a patient attempting to leave a bed so that they can be at the bedside in time to assist.

The system works via a sensor placed under a patient’s hospital bed, eliminating the need for leads or cuffs and allowing the patient freedom of movement. Using signal processing algorithms, it monitors the patient’s heart rate, breathing and movement patterns and sends the information to the nurses’ station and/or to handheld devices to the hospital’s EMR network via HL7, XML or Cerner CCM client protocol. It is also compatible with ADT and AlertingIT systems, EarlySense says.

EarlySense’s original bedside monitoring system is available in the U.S. and. The 2.0 is set for release in the U.S. in the 2014 first quarter. — Lena Freund

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