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CardioComm Solutions, Inc. Passes Canadian Medical Devices Conformity Assessment System ISO 13485:2003 Audit

January 26, 2012 6:05 am | News | Comments

TORONTO--(BUSINESS WIRE)--CardioComm Solutions, Inc., received confirmation from the Canadian Medical Devices Conformity Assessment System (CMDCAS) that it had cleared an ISO audit performed by DQS Medizinprodukte GmbH. CardioComm Solutions is registered...

Fenwal Receives New Regulatory Clearances for Amicus Separator and DXT Relay Software

January 26, 2012 5:47 am | News | Comments

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fenwal Inc., a global medical technology company focused on improving blood separation, collection, safety and availability, announced today it has received clearances from the U.S. Food and Drug Administration to market the Fenwal Amicus® separator...

BIOTRONIK Successfully Completes Testing of BIOTRONIK EHR DataSync— Connecting BIOTRONIK Home Monitoring to Electronic Health Record Systems

January 26, 2012 5:45 am | News | Comments

LAKE OSWEGO, Ore.--(BUSINESS WIRE)--BIOTRONIK, a worldwide leader in manufacturing cardiac medical devices and pioneer of remote patient management solutions, today announced it has successfully completed its final interoperability testing process for BIOTRONIK Home Monitoring®...

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Spectranetics Strengthens Peripheral Vascular Portfolio with a Partnership to Distribute the TAPAS Catheter

January 25, 2012 5:42 am | News | Comments

COLORADO SPRINGS, Colo.--(BUSINESS WIRE)--Spectranetics Corporation today announced an agreement with ThermopeutiX, Inc. to commercialize the TAPAS catheter, a therapeutic infusion system. The product has recently received U.S. Food and Drug Administration (FDA) 510(k) clearance...

Zogenix and Battelle to Collaborate on Advanced Drug Delivery Technology

January 25, 2012 5:32 am | News | Comments

The companies have signed a Letter of Intent to enter into an exclusive co-marketing and technology development option agreement to utilize Zogenix's DosePro® needle-free drug delivery technology for new commercial out-licensing opportunities. DosePro technology enables...

Ukraine Fortifies Cancer Management Capabilities with New Elekta Technology

January 25, 2012 5:10 am | News | Comments

KYIV, Ukraine /PRNewswire/ -- The Rinat Akhmetov (Development of Ukraine) Foundation took bold strides in 2011 to advance patient care by acquiring a comprehensive range of cancer management technology to equip the radiotherapy department at Rivne Regional Oncologic Dispensary in Ukraine.

PMD Healthcare Launches Spiro PD—The First Personal Spirometer to Monitor Lung Function

January 24, 2012 5:26 am | News | Comments

ALLENTOWN, PENNSYLVANIA -- PMD Healthcare Inc., announced today the launch and availability of its novel new lung health monitoring device – Spiro PD. Recently cleared by the U.S. Food and Drug Administration (FDA), Spiro PD is the first and only personal spirometer...

Guided Therapeutics Submits CE Mark Approval Application for LuViva Advanced Cervical Scan

January 24, 2012 4:50 am | News | Comments

NORCROSS, Ga.--(BUSINESS WIRE)--Guided Therapeutics, Inc. today announced that it has submitted the application for CE Mark approval for LuViva® Advanced Cervical Scan. The CE Mark is required to market LuViva in the 27 nations that comprise the European Union (EU).

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CardioComm Solutions, Inc. Receives FDA Clearance to Market First Over-the-Counter Heart Monitoring Solution

January 23, 2012 5:44 am | News | Comments

TORONTO--(BUSINESS WIRE)--CardioComm Solutions, Inc., a global medical provider of ECG acquisition and management software solutions, received clearance from the Food and Drug Administration (FDA) for over-the-counter (OTC) sales and marketing of their consumer-based...

Precision Pulmonary Diagnostics to Offer OSA Portable Monitor Testing

January 23, 2012 5:42 am | News | Comments

HOUSTON--(BUSINESS WIRE)--Precision Pulmonary Diagnostics (PPD®) recently added portable monitor testing to its diagnostic offerings of sleep apnea in commercial drivers. PPD is an industry leader, providing turn-key sleep apnea disease management program and lab network.

Medgenics' Receives Allowance for Key European Patent

January 23, 2012 5:30 am | News | Comments

MISGAV, Israel & SAN FRANCISCO--(BUSINESS WIRE)--Medgenics, Inc., the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that the Company received notice of ‘Intention to Grant'...

Guided Therapeutics Provides Update on PMA Application for LuViva Advanced Cervical Scan and Timing for Filing of CE Mark

January 23, 2012 5:27 am | News | Comments

NORCROSS, Ga.--(BUSINESS WIRE)--Guided Therapeutics, Inc. today announced that the company plans to seek an independent panel review of its Pre-market Approval (PMA) application for the LuViva® Advanced Cervical Scan from the U.S. Food and Drug Administration (FDA)...

Alere rapid flu test receives CLIA waiver from FDA

January 23, 2012 5:07 am | News | Comments

Waltham, Massachusetts – Alere Inc., a global leader in enabling individuals to take charge of their health at home through the merger of rapid diagnostics and health management, received confirmation that The U.S. Food and Drug Administration (FDA) has cleared the Alere™ Influenza A&B Test...

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Covidien Provides Update on Voluntary Recall of BIS Bilateral Sensors

January 20, 2012 5:10 am | News | Comments

BOULDER, Colo.--(BUSINESS WIRE)--On November 8, 2011, Covidien initiated a voluntary recall of certain lots of its BISâ„¢ Bilateral Sensors, due to a modification which inadvertently reversed the reference and left eye electrode. This modification could potentially cause a change...

U.S. Oncology Research Enrolls More Than 50,000 Patients Into Clinical Trials

January 20, 2012 4:46 am | News | Comments

THE WOODLANDS, Texas--(BUSINESS WIRE)-- US Oncology Research, supported by McKesson Specialty Health, announced today that it has surpassed the 50,000 milestone for patients enrolled in its clinical trials program. One of the largest community-based research networks in the world...

Toshiba's Aquilion ONE CT Facilitates Faster, Accurate Neuro Imaging at Buffalo General Medical Center Emergency Department

January 19, 2012 5:02 am | News | Comments

TUSTIN, Calif.--(BUSINESS WIRE)--Based on proven success at Millard Fillmore Gates Circle Hospital triaging stroke patients, Kaleida Health installed a second Aquilion ONE from Toshiba America Medical Systems, Inc., at Buffalo General Medical Center in Buffalo, N.Y.

SANUWAVE Issued U.S. Patent for a New Method to Produce Acoustic Shock Waves Utilizing Pressurized Fluid

January 18, 2012 5:43 am | News | Comments

ALPHARETTA, Ga.--(BUSINESS WIRE)--SANUWAVE Health, Inc. today announced that the U.S. Patent and Trademark Office (USPTO) has issued the Company patent number 8,092,401, titled “Method and Apparatus for Producing Shock Waves for Medical Applications.”

Xsens motion capture data in Siemens PLM Software Jack

January 18, 2012 5:10 am | News | Comments

ENSCHEDE, The Netherlands - Xsens, the leader in professional 3D tracking systems, today announced that it has joined the Siemens Solution Partner Program to provide its motion capture solution for the Jack™ software ergonomics package, a part of the Tecnomatix® software family...

Stem Cell Technologies Finding a Larger Market, Report Says

January 18, 2012 5:06 am | News | Comments

New York-The market for stem cell technologies will rise to over $700 million this year, and given some positive trends could reach over one billion dollars, according to healthcare market research publisher Kalorama Information. The firm cites newly permitted US usage and accompanying research...

Grifols Receives ISO 13485:2003+AC:2009 Quality Management Certification for its Medical Devices

January 18, 2012 4:50 am | News | Comments

LOS ANGELES/PRNewswire/ -- Grifols, a global healthcare company and biopharmaceutical manufacturer based in Barcelona, Spain, announced that its U.S. diagnostic and hospital divisions have received ISO 13485:2003+AC:2009 certification, an international quality standard...

BrainStorm Announces Clinical Data for Safety and Supporting Efficacy of NurOwn Based on Initial Phase I and II Results

January 17, 2012 5:27 am | News | Comments

New York, USA & Petach Tikvah, Israel - B3C newswire - BrainStorm Cell Therapeutics Inc., an innovative developer of adult stem cell technologies and Central Nervous System (CNS) therapeutics, today announced that the data from the initial patients in its ALS Phase I/II human clinical trial treated...

Miraculins Files with Health Canada for PreVu Medical Device License

January 17, 2012 5:21 am | by Associated Press | News | Comments

Miraculins Inc., a medical diagnostic company focused on developing and commercializing diagnostic tests and risk assessment technologies for unmet clinical needs, announces today that it has filed a class II medical device license application with Health Canada for the PreVu Non-Invasive...

Saudi Arabia Uses ZOLL's Temperature Management Solution to Revive Pilgrims from Heat Stroke During the Hajj Pilgrimage

January 16, 2012 5:34 am | News | Comments

CHELMSFORD, Mass.--(BUSINESS WIRE)--ZOLL® Medical Corporation, a manufacturer of medical devices and related software solutions, announced today that the Saudi Arabia Ministry of Health purchased six ZOLL intravascular temperature management (IVTM™) systems...

Lloydspharmacy Partners With Proteus Biomedical to Launch Innovative Digital Health Product

January 16, 2012 5:10 am | News | Comments

REDWOOD CITY, Calif.--(BUSINESS WIRE)--UK community pharmacy chain Lloydspharmacy and US company Proteus Biomedical, Inc., a pioneer in digital health, have today announced an exclusive strategic collaboration to commercialize and launch Heliusâ„¢, a digital health product...

Air Techniques' Polaris Given 'Top Intraoral Camera of 2012' Award

January 16, 2012 5:06 am | News | Comments

MELVILLE, N.Y.--(BUSINESS WIRE)--Air Techniques, Inc., a leading dental equipment manufacturer, announced today that its Polaris Intraoral Camera has been awarded Top Intraoral Camera of 2012 by THE DENTAL ADVISOR. Polaris offers superior optics and a broad focal range...

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