EarlySense Receives FDA ClearanceNovember 20, 2007
The company's ES-16 noncontact heart and respiration monitor has received FDA clearance and is being evaluated in a variety of clinical settings.
RAMAT-GAN, Israel--(BUSINESS WIRE)--EarlySense Ltd., developer of 'smart systems' for monitoring changes in a patient's clinical condition, announced that it has received FDA clearance for its ES-16 system. The ES-16 system, cleared by the FDA, monitors heart and respiratory rates in both children and adults.
The technology developed by EarlySense uses a proprietary contact-free sensor, meaning that it is not physically connected to the body of the patient. The ES-16 system eliminates patient discomfort and enables the cost-effective monitoring of patients in settings such as homes, hospitals and other clinic settings such as long term care facilities. The system is currently being evaluated at several clinical settings on patients suffering from chronic diseases, such as Asthma, COPD and CHF, as well as at acute care facilities, on critical care patients and patients hospitalized for various medical and post-operative conditions.
"Hospitals and other healthcare providers are facing a growing challenge in treating older and sicker patients. Such providers are looking for technological solutions that allow them to increase the quality of care and improve patient safety without adding to already stretched budgets and manpower. We have addressed this need with a smart monitoring solution that facilitates the improvement of patient safety and nursing efficiencies," said EarlySense CEO Mr. Avner Halperin.
"Providers are required to comply with a growing list of mandates intended to improve patients' care. Most recently, The Joint Commission, the primary accreditation agency in the United States, required that starting in 2008, all hospitals will need to establish systems and procedures to better recognize and respond to changes in a patient's condition. The recent FDA clearance will enable these providers to use EarlySense products to meet such specific requirements," said EarlySense Director of Clinical and Regulatory Affairs Dr. Dalia Argaman.
EarlySense intends to start selling its new product, to be named EverOn, in 2008, following a number of beta sites evaluations in both Israel and the United States.
EarlySense Ltd. was founded in 2004 by Avner Halperin, a former Vice President at Radcom and Lenslet; Yossi Gross, a founder of a number of medical device companies, including BioControl, Brainsgate, and Visioncare; Guy Shinar, former CEO of X-Technologies; and Dr. Danny Lange, founder of IDesia and Algodyne. The company is headquartered in Ramat-Gan, Israel. For additional information, please contact Marjie Hadad, Media Liaison, at +972-54-536-5220 or email@example.com.
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