PRESS
Zargis Medical Updates on FDA Submission
PRINCETON, N.J., April 6, 2004 - Zargis Medical Corp. today announced an update on the status of its Premarket Notification, 510(k), application to the Food and Drug Administration for clearance to market the Zargis Acoustic Cardioscan (ZAC) System, filed in May 2003. The ZAC System, Zargis� first clinical device, will initially be targeted toward physicians to be used as part of general medical examinations and physicals to detect murmurs.
Zargis continues its dialogue with the FDA and has submitted additional clinical data in support of the application. The FDA does not provide timelines or the likelihood of approvals. "Our most recent data is encouraging and we remain very optimistic on gaining FDA clearance on our 510(k) submission." stated Dr. Shahram Hejazi, President and CEO of Zargis.
Published studies report a prevalence of heart murmurs alone in up to 80% of children and the elderly, and approximately 20% in the adult population in the U.S. Given these statistics, an aging population and budget pressures on healthcare, there is a need for accurate auscultatory detection of heart murmurs.
Zargis Medical Corp. was formed in January 2001 when Siemens Corporate Research Inc., a subsidiary of Siemens AG (NYSE: SI), and Speedus Corp. (NASDAQ: SPDE) co-invested in Zargis to further develop and commercially market an advanced acoustic technology for detecting heart murmurs and other abnormalities. Based in Princeton, New Jersey, Zargis is developing advanced diagnostic decision support products and services for primary care physicians, cardiologists and other healthcare professionals.
For additional information about Zargis Medical Corp., contact John Kallassy, 609.734.6510, jkallassy@speedus.com, or visit their website at www.zargis.com.
For additional information on Speedus Corp, contact John Kallassy, 718.567.4358, jkallassy@speedus.com, or visit their website at www.speedus.com.
For additional information on Siemens Corporate Research, visit their website at www.scr.siemens.com.
***
Statements
contained herein that are not historical facts, including but not
limited to statements about the Company�s product, corporate
identity and focus, may be forward-looking statements that are
subject to a variety of risks and uncertainties. There are a
number of important factors that could cause actual results to
differ materially from those expressed in any forward-looking
statements made by the Company, including, but not limited to, the
continuing development of the Company�s sales, marketing and
support efforts.
CONTACT: John Kallassy of Zargis Medical Corp.; 609.734.6510; jkallassy@speedus.com
The information about this product is preliminary. The product is under development and not commercially available in the U.S., and its future availability cannot be ensured.
July 30, 2010
Veterans Administration Health Care System Purchases 15 Zargis Cardioscan Systems
July 21, 2010
Zargis Awarded U.S. Army Contract
June 11, 2010
Zargis to Launch FDA-Cleared Lung Sounds Analysis Technology from Stethographics, Inc. Exclusive License Agreement Allows Zargis to Expand into Respiratory Sounds Market
June 10, 2010
Zargis Medical Receives Top Honors at Medical Design Excellence Awards
May 27, 2010
Zargis Launches Telemedicine System with Real-Time Transmission of Stethoscope Sounds
May 13, 2010
U.S. Army to Showcase Zargis' Technology at Telemedicine Conference
April 20, 2010
3M Littmann Model 3200/Zargis Cardioscan Honored for Stethoscope/Software Design Innovation
April 12, 2010
Zargis Cardioscan Wins 'Best of the Best' red dot design award
September 29, 2009
Zargis Awarded Follow-On U.S. Army Contract; Mandates Expansion of Two Previous Awards
February 23, 2010
Zargis StethAssist & Zargis Cardioscan Cleared for Sale in Australia
February 15, 2010
Edison Best New Product Awards Taps 3M and Zargis
January 8th, 2010
Zargis Cardioscan Cleared for Sale in Canada
December 14, 2009
Zargis Cardioscan 'The Intelligent Stethoscope' Now Available on Amazon.com
December 1, 2009 - IN THE NEWS
Popular Science Magazine Innovation of the Year Issue
December 1, 2009 - IN THE NEWS
Popular Science Cardioscan Video
December 1, 2009 - IN THE NEWS
Scoping Out Stethoscopes (Contemporary Pediatrics Magazine)
November 24, 2009
Zargis Cardioscan(TM) Featured on The Early Show on CBS
November 18, 2009 - IN THE NEWS
Zargis Builds a Better Stethoscope
November 12, 2009
3M Health Care and Zargis Medical Awarded "Innovation of the Year" for Littmann(R) Model 3200 Stethoscope with Cardioscan Software
October 21, 2009
Zargis Cleared as Apple iPhone Developer; Medical Applications for Smartphones Planned
September 24, 2009
3M Global Business Manager Ingrid Blair Joins Zargis Board
September 25, 2009 - IN THE NEWS
TAMC Heart Device Approved, Deploys to Pacific Areas
September 17, 2009
Zargis Receives FDA Clearance for Signal X6 Telemedicine Device; OK Allows Delivery to US Army
August 25, 2009
Zargis Cardioscan Unveiled Through Global Marketing and Distribution Alliance With 3M Company
August 19, 2009
3M Introduces First Electronic Stethoscope with Bluetooth Wireless Capability
October 9, 2008
Zargis Receives Additional Contracts from U.S. Army
February 20, 2008
Physicians use Cardioscan to Evaluate Student Athletes during Sports Physicals
October 25, 2007
3M and Zargis Announce Global Marketing Alliance
April 18, 2007
Zargis' Cardioscan Receives Televised News Coverage
November 6, 2006
Zargis Awarded U.S. Army Contract
October 9, 2006
Study Shows Cardioscan Leads to 41% Reduction of Unnecessary and Costly Cardiac Referrals by Physicians
September 13, 2006
Study Results for Zargis Cardioscan to be Presented at American Academy of Pediatrics Conference
September 11, 2006
The Wall Street Journal Recognizes Zargis Medical With Technology Innovation Award
November 16, 2005
Panel Agrees Zargis Prototype Would Improve Referral Accuracy with Heart Murmurs
October 26, 2005
Zargis Medical Awarded Fundamental New Patent
June 30, 2005
Zargis Conducts Physician Study to Show Potential Benefits to Physicians, Insurance Companies and Patients
March 15, 2005
Zargis CTO to Speak at Medical Devices Conference
November 29, 2004
White Paper "Computer Aided Auscultation of the Heart, the Clinical Opportunity" Available at Zargis Website
November 12, 2004
Zargis Signs Exclusive Pact With Johns Hopkins University
November 5, 2004
Zargis Medical Announces the Results of a Clinical Study in Hypertrophic Cardiomyopathy (HCM)
September 14, 2004
Zargis Medical receives FDA clearance: Energy Display and Timing Annotation Added to Cardioscan
June 1, 2004
FDA Clears Zargis' Pioneering Medical Device: First Computer-Aided Device to Assist in the Detection of Heart Murmurs
April 6, 2004
Zargis Medical Updates on FDA Submission
January 12, 2004
Healthcare Veteran Joins Zargis Board
October 27, 2003
Siemens Medical Solutions Leader Joins Zargis Board
July 9, 2003
Zargis Awarded Core Patent for Acoustic Cardioscan
May 21, 2003
Zargis Medical Files with FDA for Approval of Zargis Acoustic Cardioscan System
July 15, 2002
Zargis Medical Tests New Technology, Developed at Siemens, to Improve Diagnosis of Heart Murmurs
February 20, 2002
Zargis Medical Appoints Siemens' Veteran Hejazi As President And Chief Executive Officer
March 26, 2001
Siemens' and SPEEDUS' Start-Up, Zargis Medical Corp., Announces Four Appointments to Medical Experts Board; Changes Name From Sound Diagnostics
January 16, 2001
Siemens and SPEEDUS Team Together in Start-Up to Develop Technology For Rapidly Detecting Valvular Heart Disease During Routine Patient Examinations