Navigation Links
Oridion Receives FDA 510(k) Clearance for Capnostream(TM)20 Monitor With Integrated Pulmonary Index(TM)
Date:2/22/2009

JERUSALEM and NEEDHAM, Massachusetts, February 23 /PRNewswire-FirstCall/ -- Oridion Systems Ltd. (SIX Swiss Exchange: ORIDN). Oridion Systems Ltd. has received an FDA 510(k) clearance for its Capnostream(TM)20 Monitor with Integrated Pulmonary Index(TM).

The Integrated Pulmonary Index(TM), the latest Oridion Smart Capnography(TM) initiative, utilizes sophisticated algorithms to integrate the real time measures and interactions of four complex parameters - end tidal CO2 (EtCO2), respiration rate, pulse rate and SpO2 (oxygen saturation) into a single index value. The result is displayed on a scale from 1-10, where 10 indicates optimal pulmonary status.

By using the Integrated Pulmonary Index(TM), clinicians can quickly and easily assess a patient's ventilation status and monitor a patient's changing condition, thus facilitating more timely interventions to reduce patient risk and improve outcomes.

The Integrated Pulmonary Index(TM) has been clinically validated as evidenced by medical research studies conducted and presented at major conferences in 2008 and 2009. At the recent annual meeting of the Society for Technology in Anesthesia (STA) in San Antonio, Texas, research findings were presented by Dr. David Gozal, MD from Hadassah University Hospital and Prof. Ya'acov Gozal, MD from Shaare Zedek Medical Center, both in Jerusalem, on the validity and application of the Integrated Pulmonary Index(TM) in the pediatric population. The study concluded the Integrated Pulmonary Index(TM) would be "particularly useful for non-expert personnel monitoring patients undergoing procedures requiring sedation or recovering from them". Based on a further study on its reliability in the post-operative setting, Prof. Ya'acov Gozal stated that since the Integrated Pulmonary Index(TM) is displayed as a single value, "it may simplify the monitoring of patients in a busy PACU."

In addition, a study presented at the American Society of Anesthesiologists (ASA) in Orlando, Florida in October, 2008, demonstrated how the Integrated Pulmonary Index(TM) provides an accurate, uncomplicated and inclusive assessment of a patient's ventilatory status.

"We are encouraged and delighted by this FDA clearance," said Gerry Feldman, President of Oridion. "Oridion has worked hard to develop safer and easier patient safety technologies. The Integrated Pulmonary Index(TM) will make sophisticated determinations of pulmonary adequacy far more efficient for the diagnosing clinician. More importantly, it will enable the general floor nurse to confidently decide when to call for help. Our mission is to take risk and cost out of medicine and the Integrated Pulmonary Index(TM) is an important success on that journey."

Oridion is the global leader of capnography monitoring solutions and its Microstream(R) capnography technology is the standard of care in ventilation monitoring.

About Oridion

Oridion Systems Ltd. (www.oridion.comwww.oridion.com) is a global medical device company specializing in patient safety monitoring. The Company operates through wholly owned subsidiaries in the United States, Europe, and Israel.

Oridion develops proprietary medical devices and patient interfaces, based on its patented Microstream(R) technologies, for the enhancement of patient safety through the monitoring of the carbon dioxide (CO2) in a patient's breath. These products provide effective, proven airway management and are used in various clinical environments, including procedural sedation, pain management, operating rooms, critical care units, post-anesthesia care units, emergency medical services, transport, alternate care and other settings where patients' ventilation may be compromised and at risk.

Certain statements made herein that are not historical are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words "estimate" "project" "intend" "expect" "believe" and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, among others, our ability to maintain profits, the market demands for our Capnography products, our ability to focus our team on the Capnography business, changes in general economic and business conditions, inability to maintain market acceptance to the Company's products, inability to timely develop and introduce new technologies, products and applications, rapid changes in the market for the Company's products, loss of market share and pressure on prices resulting from competition, introduction of competing products by other companies, inability to manage growth and expansion, loss of key OEM partners, inability to attract and retain qualified personnel, inability to protect the Company's proprietary technology.

Furthermore, this press release does not constitute an offer to sell or a solicitation of an offer to buy any securities. The Company's shares issued have not been, and will not be, registered under the US Securities Act of 1933, as amended (the "Securities Act"), or under any of the relevant Securities Laws of any state of the United States. The Company's shares may not be offered, sold or delivered, directly or indirectly, to, or for, the account of any US person (as defined in regulation S under the Securities Act) in or into the United States, or by use of the US mail, or by any means or instrumentality of United States interstate commerce, absent registration, or an exemption from registration under the Securities Act.

    For further Oridion information please contact

    Alan Adler, Chairman and Chief Executive Officer
    Walter Tabachnik, Chief Financial Officer
    Elena Gerberg, Investor Relations
    e-mail: investor@oridion.com
    website:http://www.oridion.com
    phone: +972-2-589-9159
    address: Oridion Systems Ltd., P.O. Box 45025, 91450 Jerusalem, Israel


'/>"/>
SOURCE Oridion Systems Ltd.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Oridion Signs Strategic Development and Marketing Agreement with Global Healthcare Company
2. Oridion Introduces New Smart Capnography System for Improved Patient Safety
3. Abbott Receives European Commission Clearance on Acquisition of Advanced Medical Optics
4. Regenstrief Institute receives World Health Organization designation
5. CONBRIZA Receives Positive CHMP Opinion for the Treatment of Postmenopausal Osteoporosis in Women at Increased Risk of Fracture
6. Osteotech Receives 13485:2003 ISO Certification; Company Meets International Standards for Medical Device Manufacturing
7. Cipher receives tentative FDA approval for extended-release tramadol capsules
8. China Shenghuo Receives Notice from NYSE Alternext US Regarding Listing Standards
9. A Drug That Receives Regulatory Approval for Cognitive Impairment Associated With Schizophrenia Would Earn a Higher Patient Share in the United States Than in Europe
10. i.HUG Foundation Receives International Grant: Hires a School Nurse to Improve Student Health and Learning
11. Emageon Receives Escrowed Funds and Terminates Merger Agreement
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, ... Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments in ... the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in ...
(Date:6/24/2016)... ... ... June 19, 2016 is World Sickle Cell Observance Day. In an effort ... holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued a pain ... Disease (SCD) is a disorder of the red blood cells, which can cause episodes ...
(Date:6/24/2016)... ... 24, 2016 , ... Dr. Amanda Cheng, an orthodontist ... has extensive experience with all areas of orthodontics, including robotic Suresmile technology, ... , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. It can be used ...
(Date:6/24/2016)... ... June 24, 2016 , ... EB Medicine ... Making in Emergency Medicine conference in Ponte Vedra Beach, FL. The awards honor ... Emergency Medicine Practice and Pediatric Emergency Medicine Practice. , “With this ...
(Date:6/24/2016)... ... 24, 2016 , ... National recruitment firm Slone Partners is pleased ... and genomics experience, as Vice President of North American Capital Sales at HTG ... leading the sales team in the commercialization of the HTG EdgeSeq system and associated ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016  Global Blood ... biopharmaceutical company developing novel therapeutics for the treatment ... today announced the closing of its previously announced ... stock, at the public offering price of $18.75 ... offering were offered by GBT. GBT estimates net ...
(Date:6/24/2016)... June 24, 2016 ... announced the addition of the " Global Markets ... This report focuses ... an updated review, including its applications in various applications. ... market, which includes three main industries: pharmaceutical and biotechnology, ...
(Date:6/24/2016)... , June 24, 2016 The Academy ... of recommendations that would allow biopharmaceutical companies ... with entities that make formulary and coverage decisions, a ... "value" of new medicines. The recommendations address ... not appear on the drug label, a prohibition that ...
Breaking Medicine Technology: