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ASTRO commends CMS for limiting payment reductions proposed for radiation oncology

ASTRO, the American Society for Radiation Oncology, today praised the Centers for Medicare and Medicaid Services (CMS) for limiting the payment reductions initially proposed for radiation oncology and spreading the remaining cuts over four years.

3 Nov 2009

FDA: Guidance document on diagnostic tests for the 2009 H1N1 influenza virus

The U.S. Food and Drug Administration today published a guidance document that should help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic, manufacturers can submit a request to the FDA for an Emergency Use Authorization (EUA).

3 Nov 2009

New imaging technique for treatment of breast cancer

Researchers at Rush University Medical Center and Argonne National Laboratory are collaborating on a study to determine if an imaging technique used by NASA to inspect the space shuttle can be used to predict tissue damage often experienced by breast cancer patients undergoing radiation therapy. The study is examining the utility of three-dimensional thermal tomography in radiation oncology.

3 Nov 2009

Cardium Therapeutics to seek FDA marketing clearance for ExcellagenXL

Cardium Therapeutics today announced plans to submit a 510(k) premarket notification with the U.S. Food and Drug Administration (FDA) seeking marketing clearance of its ExcellagenXL(TM) product candidate.

3 Nov 2009

Cambridge Research & Instrumentation launches inForm image analysis software

Cambridge Research & Instrumentation, Inc. (CRi), a leader in biomedical imaging, today announced the launch of inForm™, advanced image analysis software based on the company’s proprietary Machine Learning System (MLS). inForm solves biologists’ and cancer researchers’ challenging image analysis problems by combining fast and easy-to-use automated image processing with advanced learning features that enable the user to train the software to process images automatically.

3 Nov 2009

ART Advanced Research Technologies to secure $1.2M interim financing

ART Advanced Research Technologies Inc., a Canadian medical device company and a leader in optical molecular imaging products for the healthcare and pharmaceutical industries, announced that earlier today it filed a notice of intention to make a proposal to its creditors under the Bankruptcy and Insolvency Act with KPMG Inc. in order to provide the company with the liquidity it requires to pursue its solicitation process.

2 Nov 2009

superDimension launches the iLogic electromagnetic navigation bronchoscopy tool

superDimension, Inc.®, a private company that develops minimally invasive interventional pulmonology devices, announced today the launch of the iLogic System for early lung cancer detection and diagnosis. The device is the second generation version of inReach(TM), superDimension's electromagnetic navigation bronchoscopy (ENB) minimally invasive tool.

2 Nov 2009

St. David's Medical Center to use FDA cleared CARTO 3 Navigation System for treating cardiac arrhythmia

On Monday, November 2, 2009, Andrea Natale, M.D., F.A.C.C., F.H.R.S., an electrophysiologist and executive medical director of the Texas Cardiac Arrhythmia Institute at St. David's Medical Center, will be the first physician in the United States to perform an ablation procedure to treat a patient with a cardiac arrhythmia, commonly known as an irregular heart rhythm, using the newly FDA-cleared CARTO® 3 Navigation System.

2 Nov 2009

Phase Forward to support FDA's production rollout of the WebSDM tool

Phase Forward, a leading provider of data management solutions for clinical trials and drug safety, today announced a contract award to support the FDA’s production rollout of the company’s WebSDM™ Release 3.0 software, including the Empirica™ Study Clinical Trials Signal Detection system.

2 Nov 2009

Atrial fibrillation device market will grow by almost 10% through 2013: MRG

According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, the atrial fibrillation device market will grow by almost 10% through 2013 in the US, Europe, and Japan. MRG's Global Markets for Atrial Fibrillation Devices 2009 report finds that many patients will be treated with electrophysiology technology and related devices as positive clinical results supporting their use emerges.

2 Nov 2009

AllOne Health partners with Connectyx Technologies Holdings to provide health information on the Web

AllOne Health(SM) and Connectyx Technologies Holdings Group, Inc. (Pink Sheets: CTYX) today announced a partnership that will allow consumers to view and manage health information on the Web, via portable USB storage devices and through their mobile phones, with one, secure step. A package including both companies' products will be sold in retail stores across the U.S. in December.

2 Nov 2009

John C. Lincoln Hospital first to use commercially-available LungPoint system

Broncus Technologies, Inc., a medical device company focused on developing minimally-invasive innovations for lung diseases, announced today at the American College of Chest Physicians CHEST 2009 meeting that John C. Lincoln Hospital in Phoenix is the first hospital in the U.S. to use the commercially-available LungPoint system.

2 Nov 2009

New glucose monitoring system from Edwards Lifesciences and Dexcom receives the CE Mark

Edwards Lifesciences Corporation, the leader in the sciences of heart valves and hemodynamic monitoring, and DexCom, Inc., a medical device company focused on the design, development and commercialization of continuous glucose monitoring systems, today announced the receipt of CE Mark for an automatic glucose monitoring system.

2 Nov 2009

Click4Care releases next-generation Utilization Management module for health plan users

Click4Care, a leading provider of care management software for payors, today announced the next-generation Utilization Management (UM) module for its industry leading software platform. By leveraging the UM solution’s extensive configurability, payors and providers can achieve greater levels of productivity while improving clinical, administrative and financial performances.

2 Nov 2009

NIH awards $1.2 million to GE Global Research to develop a low-cost transducer

In the quest to expand access to high quality prenatal care to communities with limited healthcare services, GE Global Research, the technology development arm for the General Electric Company, has been awarded a two-year, $1.2 million project under the federal stimulus program from the National Institute of Biomedical Imaging and Bioengineering, part of the National Institutes of Health (NIH) to develop a low-cost transducer for portable ultrasound systems that maintains the highest degree of image quality.

2 Nov 2009

Cyberonics to develop medical devices with cutting edge technology for persons suffering from epilepsy

Cyberonics, Inc. today announced another in a series of collaborations around seizure detection technology aimed at advancing its development of new and more efficacious medical devices for persons suffering from epilepsy.

2 Nov 2009

Aribex alleges patent infringement of its handheld X-ray, files a complaint against Bio-Ray Prox

Aribex, Inc., of Orem, Utah, today announced that it has filed a patent infringement complaint for unspecified damages against manufacturer DigiMed Co., Ltd (of Seoul, Korea), Sigma Biomedics (of Buffalo Grove, Illinois), and Dentalaire Products (of Fountain Valley, Calif.). Sigma and Dentalaire distribute the Bio-Ray Prox, a portable X-ray device which is manufactured in Korea by DigiMed.

2 Nov 2009

2009 EACTS Techno-College Innovation Award to Clear Catheter Systems for its PleuraFlow system

Clear Catheter Systems, a private medical device company pioneering proprietary medical catheter anti-occlusion technologies, has been awarded the 2009 EACTS Techno-College Innovation Award for its PleuraFlow Active Tube Clearance System. The Techno-College Award is a worldwide competition to identify innovations with the potential to change the standard of care in heart and lung surgery.

2 Nov 2009

DSPA chooses SAS Solutions OnDemand as a technology platform for clinical development

SAS announced today that Dainippon Sumitomo Pharma America, Inc. (DSPA), a U.S. pharmaceutical company, has selected SAS Solutions OnDemand: Drug Development as a technology platform for clinical development. With SAS OnDemand, DSPA will have a globally accessible, fully regulatory compliant repository for all of its clinical data.

2 Nov 2009

Online interactive pancreatic cancer awareness campaign launched

In recognition of National Pancreatic Cancer Awareness Month, the Pancreatic Cancer Action Network is issuing a challenge to increase the number of people aware of the deadly disease through an online interactive campaign "Pancreatic Cancer: Know it. Fight it. End it."

2 Nov 2009

Device / Technology News

ASTRO commends CMS for limiting payment reductions proposed for radiation oncology

FDA: Guidance document on diagnostic tests for the 2009 H1N1 influenza virus

New imaging technique for treatment of breast cancer

Cardium Therapeutics to seek FDA marketing clearance for ExcellagenXL

Cambridge Research & Instrumentation launches inForm image analysis software

ART Advanced Research Technologies to secure $1.2M interim financing

superDimension launches the iLogic electromagnetic navigation bronchoscopy tool

St. David's Medical Center to use FDA cleared CARTO 3 Navigation System for treating cardiac arrhythmia

Phase Forward to support FDA's production rollout of the WebSDM tool

Atrial fibrillation device market will grow by almost 10% through 2013: MRG

AllOne Health partners with Connectyx Technologies Holdings to provide health information on the Web

John C. Lincoln Hospital first to use commercially-available LungPoint system

New glucose monitoring system from Edwards Lifesciences and Dexcom receives the CE Mark

Click4Care releases next-generation Utilization Management module for health plan users

NIH awards $1.2 million to GE Global Research to develop a low-cost transducer

Cyberonics to develop medical devices with cutting edge technology for persons suffering from epilepsy

Aribex alleges patent infringement of its handheld X-ray, files a complaint against Bio-Ray Prox

2009 EACTS Techno-College Innovation Award to Clear Catheter Systems for its PleuraFlow system

DSPA chooses SAS Solutions OnDemand as a technology platform for clinical development

Online interactive pancreatic cancer awareness campaign launched

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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