Navigation Links
Rcadia COR Analyzer System Receives Expanded FDA Clearance to Rule Out Coronary Artery Disease in Coronary Branch Vessels
Date:2/9/2011

NEWTON, Mass., Feb. 9, 2011 /PRNewswire/ -- Rcadia Medical Imaging announced today that it has received FDA 510(k) marketing clearance for an enhanced version of its COR Analyzer® System to assess coronary branch vessels in addition to main coronary arteries in patients with suspected coronary artery disease (CAD). The clearance is the third for the COR Analyzer System, a unique clinical decision support tool that automatically detects significant (50 percent and over) stenotic lesions in coronary arteries from Coronary CT Angiography (cCTA) studies.

"The enhanced version expands the benefits of the COR Analyzer System as a powerful complement to cCTA in evaluating suspected CAD patients," said Shai Levanon, President and CEO of Rcadia. "By providing rapid detection of stenotic lesions our system enables expanded use of cCTA to enhance patient care and reduce unnecessary costs."

The FDA clearance follows the recent publication of the first clinical study evaluating the COR Analyzer's enhanced version. The study, published (online) in Academic Radiology in January 2011 by researchers at Thomas Jefferson University, demonstrated that the "COR Analyzer provides a high negative predictive value for the absence of coronary disease in branch vessels as well as the major coronary arteries."  

The retrospective study, conducted by Ethan Halpern, MD, and David Halpern, compared 207 cases evaluated by the COR Analyzer System with expert interpretation. The final clinical interpretation identified 48 patients with significant (over 50 percent) stenosis. The COR Analyzer System demonstrated a sensitivity of 92 percent and a negative predictive value of 97 percent. In the study, the system's specificity was 70 percent and the positive predictive value was 48 percent.

The investigators noted that the "high negative predictive value will be most useful in a population with a low prevalence of coronary disease - such as the emergency room chest pain population - where the COR Analyzer might be used to facilitate the rapid discharge of a majority of patients who have normal coronary CTA studies during all hours of the day or night."

About Rcadia Medical Imaging

Rcadia Medical Imaging Ltd. develops and markets proprietary computerized systems that automatically detect clinical abnormalities in digital medical images, particularly for patient triage in emergency, life threatening conditions. The company's first FDA-cleared product, the COR Analyzer® System, provides fully automated, real-time analysis of Coronary CT angiography to enable the practical application of cCTA in detecting significant coronary artery disease. The COR Analyzer improves the utility of Coronary CTA studies in the emergency department to triage chest pain patients and optimizes work flow in cardiology and radiology departments. Learn more at www.rcadia.com.


'/>"/>
SOURCE Rcadia Medical Imaging
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Rcadias COR Analyzer Family of Products Receives Second FDA Clearance
2. Clinical Trial Results on the Sleep-Promoting Effects of Vanda Pharmaceuticals Circadian Regulator Tasimelteon (VEC-162) Published in The Lancet
3. Rcadia Medical Imaging Wins 2009 AuntMinnie.com Best New Radiology Vendor Award
4. Arcadia Resources Announces Webcast of Its Fiscal 2010 Second Quarter Conference Call
5. Arcadia Resources to Present at Lazard Healthcare Conference in New York
6. Arcadia Resources Names Stephen Goldsmith to Board of Directors
7. Rcadia Medical Imaging’s COR Analyzer(R) System Receives CE Mark
8. Marcadia and Lilly Sign Development, License Agreement for Novel Glucagon Program in Severe Hypoglycemia
9. Rcadia Announces Five COR Analyzer® Studies to be Presented at SCCT Annual Scientific Meeting
10. Arcadian Healths Chief Information Officer to Address Role of CIOs from a Healthcare Perspective at the CIO Executive Leadership Roundtable in Santa Monica
11. Arcadia Resources Announces Improved Fiscal 2011 Second Quarter Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016 Roche (SIX: ... 510(k) clearance for its Elecsys BRAHMS PCT (procalcitonin) assay ... sepsis or septic shock. With this clearance, Roche is ... a fully integrated solution for sepsis risk assessment and ... with bacterial infection and PCT levels in blood can ...
(Date:6/23/2016)... , June 23, 2016 Bracket , ... launch its next generation clinical outcomes platform, Bracket eCOA (SM) ... held on June 26 – 30, 2016 in ... first electronic Clinical Outcome Assessment product of its kind to ... #715. Bracket eCOA 6.0 is a flexible platform ...
(Date:6/23/2016)... LONDON , June 23, 2016 ... environments  Oticon , industry leaders in ... the launch of Oticon Opn ™, the world,s ... world of possibilities for IoT devices.      ... Opn, Oticon introduces a number of ,world firsts,: ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... ... TherapySites, the leading website and online marketing ... Association. This new relationship allows TherapySites to continue to extend their online ... and promotional offers. , "TCA is extremely excited about this new partnership, as ...
(Date:6/27/2016)... ... June 27, 2016 , ... TopConsumerReviews.com recently awarded their highest five-star rating to ... of individuals in the United States and Canada wear eyeglasses. Once considered to be ... vision and make a fashion statement. Even celebrities use glasses as a way of ...
(Date:6/26/2016)... ... ... Pixel Film Studios Released ProSlice Levels, a Media Slicing Effect Plugin ... whole new perspective by using the title layers in ProSlice Levels to split-up ... Levels contains over 30 Different presets to choose from. FCPX users can ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women are ... with endometriosis. These women need a treatment plan to not only alleviate symptoms ... can help for preservation of fertility and ultimately achieving a pregnancy. The specialists ...
(Date:6/25/2016)... ... ... temporary closing of Bruton Memorial Library on June 21 due to a possible lice infestation, ... aspect of head lice: the parasite’s ability to live away from a human host, and ... necessary one in the event that lice have simply gotten out of control. , As ...
Breaking Medicine News(10 mins):