Navigation Links
EarlySense's EverOn(TM) System Receives FDA Clearance and CE Mark Certification
Date:6/8/2009

RAMAT GAN, Israel, June 8 /PRNewswire/ -- EarlySense announced today that its EverOn contact-free patient supervision system has been cleared for marketing by the U.S. Food and Drug Administration and has received a CE Mark certification from KEMA, a Dutch notified body, in accordance with the EC-Directive 93/42/EEC. Both allow EverOn for use with children and adults, in a home, hospital or clinical setting. In November 2007, EarlySense announced the FDA clearance of the ES-16, the predecessor of the EverOn system.

EverOn is a wireless patient supervision system installed underneath a bed mattress. There are no leads or cuffs to connect to the patient. The system measures patient vital signs and movements and alerts nurses or caregivers of any change in condition. EverOn detects heart and respiration rates, bed entries and exits, as well as patient movement. EverOn also helps medical staff to better implement patient turns, which can positively influence the treatment and the prevention of pressure ulcers. EverOn's trend line display is designed to assist clinicians in monitoring the progression of a patient's health and support improved medical decision making.

"Today's FDA clearance and CE Mark news further validates our technology. There is an unquestioned need for a system that provides a virtual safety net for patients in hospitals and provides early warnings of physiological changes that may lead to patient deterioration. EverOn enables clinicians to intervene earlier and helps improve outcomes," said Mr. Avner Halperin, CEO of EarlySense.

EverOn's advanced sensing and software technology is currently being pre-market tested at leading hospitals and hospital networks in Israel, the U.S. and Europe. The market launch of the device is expected soon.

"Feedback from our principal investigators as well as the approval by the regulatory authorities indicate that the technology is effective, useful and unique in its deliverables. We strongly believe that EverOn will make a positive impact on the future of clinical practice and improve patient care both at the hospital and in post acute care settings," said Dalia Argaman, vice president of clinical and regulatory affairs at EarlySense.

About EarlySense:

EarlySense is bringing to market a pioneering technology designed to advance proactive and preventive patient supervision to enable better patient outcomes. EarlySense is headquartered in Ramat-Gan, Israel.

For additional information, please visit http://www.earlysense.com.

Press contact: Marjie Hadad, media liaison, at marjie.hadad@earlysense.com or at +972-54-536-5220.


'/>"/>
SOURCE EarlySense
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. First ASMS Hites Award for Outstanding Research Publication Presented to Prof. Alison Ashcroft for Her Use of Waters Synapt HDMS System to Explore Protein Complexes
2. Prometheus Research Signs 3-Year Contract With Simons Foundation to Expand HTSQL Informatics System for Autism Research
3. Delcath Systems Granted Third Orphan Drug Designation
4. Boston Scientifics SpyGlass(R) Direct Visualization System Featured in Broad Range of Clinical Studies at Upcoming Digestive Disease Week(R)
5. FDA Clears Boston Scientifics SpyScope(R) Access and Delivery Catheter for Use in Endoscopic Procedures Throughout Pancreatico-Biliary System
6. Penguin Computing Forms OEM Agreement with Applied Biosystems for Scyld ClusterWare
7. Angiotech Pharmaceuticals announces FDA approval of next-generation TAXUS(R) Liberte(R) Atom(TM) Stent system
8. FDA Approves Boston Scientifics Next-Generation TAXUS(R) Liberte(R) Atom(TM) Stent System
9. SANYO Donates Air Purification Systems Effective Against Flu Viruses to New York Airports and Schools
10. Dealzer Hydroponics Introduces the Super-File Cabinet Grow Box System
11. Smith & Nephew Endoscopy Launches the BICEPTOR(TM) Tenodesis System, the First All-Arthroscopic Procedure for Biceps Tendon Repair
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/10/2017)... ... October 10, 2017 , ... ... antibody-drug conjugate (ADC) therapeutics, today confirmed licensing rights that give it exclusive ... a technology developed in collaboration with Children’s Hospital Los Angeles (CHLA). ...
(Date:10/10/2017)... ... 2017 , ... Dr. Bob Harman, founder and CEO of VetStem Biopharma, ... The event entitled “Stem Cells and Their Regenerative Powers,” was held on ... DVM, MPVM was joined by two human doctors: Peter B. Hanson, M.D., Chief of ...
(Date:10/10/2017)... 2017 SomaGenics announced the receipt of a ... RealSeq®-SC (Single Cell), expected to be the first commercially ... microRNAs) from single cells using NGS methods. The NIH,s ... accelerate development of approaches to analyze the heterogeneity of ... techniques for measuring levels of mRNAs in individual cells ...
(Date:10/10/2017)... (PRWEB) , ... October 10, 2017 , ... ... recipients of 13 prestigious awards honoring scientists who have made ... in a scheduled symposium during Pittcon 2018, the world’s leading conference and exposition ...
Breaking Biology Technology:
(Date:4/19/2017)... New York , April 19, 2017 ... competitive, as its vendor landscape is marked by the ... the market is however held by five major players ... Safran. Together these companies accounted for nearly 61% of ... of the leading companies in the global military biometrics ...
(Date:4/17/2017)... NXT-ID, Inc. (NASDAQ: NXTD ) ("NXT-ID" ... its 2016 Annual Report on Form 10-K on Thursday April 13, ... ... the Investor Relations section of the Company,s website at http://www.nxt-id.com ... http://www.sec.gov . 2016 Year Highlights: ...
(Date:4/13/2017)... According to a new market research report "Consumer ... Administration, and Authorization), Service, Authentication Type, Deployment Mode, Vertical, and Region - ... to grow from USD 14.30 Billion in 2017 to USD 31.75 Billion ... ... MarketsandMarkets Logo ...
Breaking Biology News(10 mins):