Israeli medical device company EarlySense Ltd. announced today that its EverOn Central Display Station — which accompanies its EverOn Touch patient monitoring system — was cleared the Food & Drug Administration.
The 510(k) clearance covers the ability to collect real-time vital sign information from up to three dozen EverOn bedside monitors and display the information on a computer screen at a nurse’s station. The information also is displayed on large LCDs on medical or surgical floors, enabling clinicians to continuously monitor patients.
“Today’s FDA clearance news allows us to provide hospitals with a comprehensive solution that enables proactive patient care,” said EarlySense CEO Avner Halperin in a prepared statement.
“This is achieved by delivering critical vital sign and patient safety information from the bedside to the nurses and physicians, wherever they are," he said. "With today’s increased focus on improved quality and patient safety targets coupled with the challenges of shrinking budgets, hospitals are turning to advanced technologies such as EverOn to provide effective alerts on high risk situations.”
The EverOn Touch patient-supervision system goes underneath a hospital bed mattress. The device measures a patient’s vital signs, such as heart and respiration rates, as well as movements to alert caregivers about his or her medical condition, according to the company.
In late June, EarlySense received FDA clearance to sell its EverOn Touch system in the United States. Earlier that month, EarlySense raised $13 million from mostly Israeli investment firms to launch its improved monitoring system in the United States and Europe. Bridge Investment Fund in Cleveland also is an investor and participated in the recent fundraising round.
The company last year received a grant commitment from the Global Cardiovascular Innovation Center led by the Cleveland Clinic. At that time, EarlySense said it planned to establish a base of operations in the Cleveland area to develop the next version of its patient-monitoring device.
