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Computer reminders produce smaller-than-expected improvements

Computer reminders to physicians regarding prescribing produce much smaller improvements than initially expected, found a study in CMAJ

9 Mar 2010

Corning Lab for Cure program

Corning Incorporated today announced the Corning Lab for the Cure™ program, a first-of-its-kind corporate sponsorship agreement with Susan G. Komen for the Cure®.

9 Mar 2010

Viatronix V3D-Colon software used for the President's colon cancer screening exam

Viatronix Incorporated, a Stony Brook, New York, based company announced that its V3D-Colon software is used at the National Naval Medical Center where the President's annual physical was done. "Our software is being utilized at several DOD facilities since the landmark Virtual Colonoscopy clinical trial published in the New England Journal of Medicine back in December 2003," said Zaffar Hayat, President of Viatronix Incorporated.

9 Mar 2010

BIO-key International's accuracy improves by 23% on DHS2 Dataset

BIO-key International, Inc., a leader in finger-based biometric identification solutions, today announced that in the recent test results published by the National Institute of Standards and Technology (NIST), BIO-key's accuracy improved by a remarkable 23% on the DHS2 Dataset.

9 Mar 2010

Positive results from international study of Oncotype DX breast cancer RS

Genomic Health, Inc. today announced the publication of positive results from a large international study which demonstrated that the Oncotype DX® breast cancer Recurrence Score® (RS) result is a significant independent predictor of distant recurrence in both node-negative and node-positive, hormone receptor-positive, postmenopausal breast cancer patients who are treated with either anastrozole or tamoxifen.

9 Mar 2010

Comparative study reveals no clinical advantages of mobile bearing knee systems over fixed bearing knee systems

Stryker Corporation's Orthopaedics' division today announced at the American Academy of Orthopaedic Surgeons Conference that its recent FDA-monitored Investigational Device Exemption study found no statistical difference in clinical outcomes between its mobile bearing and traditional fixed bearing knee systems. In contrast, Stryker continues to be very pleased with the success of its fixed bearing Triathlon Knee System with X3 Advanced Bearing Technology, which offers significant advantages over mobile bearing knees on wear rates and overall value.

9 Mar 2010

Edward Hospital: ER wait times available through text message, online and phone

Edward Hospital is among the first hospitals in the country to make Emergency Room wait times available via text message, online and by phone.

9 Mar 2010

BG Medicine enters into development and commercialization agreement with Abbott Laboratories

BG Medicine, Inc. today announced that it has entered into an agreement with Abbott Laboratories to extend its current development and commercialization collaboration to include the development of a galectin-3 test for Abbott Point of Care’s i-STAT® System.

9 Mar 2010

X-spine Systems, Gamma Spine announce exclusive agreement for minimally invasive spinal fixation technology

X-spine Systems, Inc., a global manufacturer of implants and instruments for spinal surgery, announced today that it has entered into an exclusive license agreement with Gamma Spine for the development and distribution of its minimally invasive spinal fixation technology. Gamma Spine, founded by Dr. Vijay Goel, Ph.D., will participate in the development process with X-spine.

9 Mar 2010

PDVI launches new web site for tracking dengue fever epidemics

PDVI, a program of the International Vaccine Institute funded by the Bill & Melinda Gates Foundation, announces today the launch of http://www.denguewatch.org, a news hub for tracking dengue fever epidemics worldwide.

9 Mar 2010

Fenwal receives FDA marketing clearance for Amicus blood cell separator

Fenwal, Inc., a global medical technology company focused on improving blood collection, separation, safety and availability, announced today that the U.S. Food and Drug Administration has granted Fenwal 510(k) clearance to market its Amicus® blood cell separator for collecting human platelets stored in InterSol® platelet additive solution (PAS 3). Fenwal's InterSol® solution was approved by the FDA in December 2009 under a new drug application. It is the first and only platelet additive solution now available in America.

9 Mar 2010

Orthofix International announces sale of vascular business assets to Covidien

Orthofix International N.V. announced today it has sold the assets of its vascular business, including its AV-Impulse® mechanical compression technology, to Covidien.

9 Mar 2010

DermaGenoma releases The HerpesDX Genetic Test for Frequent Genital Herpes

Molecular dermatology research and development innovator DermaGenoma, Inc. today released The HerpesDX Genetic Test for Frequent Genital Herpes. The new screening test will help doctors assess patients’ risk for developing frequent Genital Herpes (HSV-2) outbreaks.

9 Mar 2010

FDA grants Axis Surgical Technologies marketing clearance for C-MOR Visualization Device

Axis Surgical Technologies, Inc., announced today that it has received 510(k) clearance from the Food and Drug Administration to market their C-MOR™ Visualization Device for use in diagnostic and operative arthroscopic and endoscopic procedures. The self-contained portable direct-imaging tool provides illumination and visualization of an interior cavity through either a natural or surgical opening.

8 Mar 2010

Rcadia Medical Imaging receives CE Mark for COR Analyzer System

Rcadia Medical Imaging today announced that it has received a CE Mark for the COR Analyzer® System, its proprietary software that helps identify patients with significant CAD (Coronary Artery Disease) by a fully automatic analysis of coronary CT angiography (cCTA) studies. The CE Mark allows the company to market the system in the European Union and other countries that accept the CE Mark registration. The COR Analyzer is marketed in the U.S. under 510(k) clearance and Rcadia was named 2009 Best New Radiology Vendor by AuntMinnie.com.

8 Mar 2010

invendo medical seeks premarket clearance for new C20 colonoscopy system

invendo medical announced today that the company has filed its 510(k) notice submission with the Food and Drug Administration for premarket clearance of the company's new C20™ colonoscopy system including the SC20™ single-use colonoscope. This is the first FDA submission for invendo medical in the United States.

8 Mar 2010

Replication Medical receives CE mark for GelFix Posterior Spinal Distraction implant

Replication Medical, Inc., a developer of proprietary, hydrogel based products for the spine and other surgical applications, announced today that it has received a CE mark for its GelFix Posterior Spinal Distraction implant. A CE mark is the quality assurance certification requirement recognized by members of the European Union for sales into those countries.

8 Mar 2010

biospace med receives FDA 510(k) clearance for sterEOS 2D/3D workstation for pediatric use in spine applications

biospace med announced today that it has received 510(k) clearance from the FDA to market the Company’s sterEOS 2D/3D workstation for pediatric use in spine applications. The Company’s EOS ultra-low-dose imager previously has been FDA-cleared for use in pediatrics and adults, while sterEOS has previously been FDA-cleared for adult use in spine.

8 Mar 2010

SensAble Technologies' digital dentistry product line receives $8M infusion

SensAble Technologies, Inc®, a leading provider of 3D modeling software, haptic devices and dental restoration design and fabrication solutions, announced that it has received an $8 million investment to propel sales, marketing and engineering efforts for its digital dentistry product line. Existing investor HLM Venture Partners led the round and was joined by North Bridge Venture Partners, both of whom are headquartered in the Boston area, and have extensive expertise with medical device company funding.

8 Mar 2010

iCAD granted patent covering SecondLook Digital CAD solution incorporating lesion metrics

iCAD, Inc., an industry-leading provider of advanced image analysis and workflow solutions for the early identification of cancer, announces that the United States Patent and Trademark Office recently granted the company Patent Number 7,660,448. This patent covers future iterations of iCAD’s SecondLook® Digital Computer-Aided Detection (CAD) solution with potential application to the company’s other image analysis solutions.

8 Mar 2010

Device / Technology News

Computer reminders produce smaller-than-expected improvements

Corning Lab for Cure program

Viatronix V3D-Colon software used for the President's colon cancer screening exam

BIO-key International's accuracy improves by 23% on DHS2 Dataset

Positive results from international study of Oncotype DX breast cancer RS

Comparative study reveals no clinical advantages of mobile bearing knee systems over fixed bearing knee systems

Edward Hospital: ER wait times available through text message, online and phone

BG Medicine enters into development and commercialization agreement with Abbott Laboratories

X-spine Systems, Gamma Spine announce exclusive agreement for minimally invasive spinal fixation technology

PDVI launches new web site for tracking dengue fever epidemics

Fenwal receives FDA marketing clearance for Amicus blood cell separator

Orthofix International announces sale of vascular business assets to Covidien

DermaGenoma releases The HerpesDX Genetic Test for Frequent Genital Herpes

FDA grants Axis Surgical Technologies marketing clearance for C-MOR Visualization Device

Rcadia Medical Imaging receives CE Mark for COR Analyzer System

invendo medical seeks premarket clearance for new C20 colonoscopy system

Replication Medical receives CE mark for GelFix Posterior Spinal Distraction implant

biospace med receives FDA 510(k) clearance for sterEOS 2D/3D workstation for pediatric use in spine applications

SensAble Technologies' digital dentistry product line receives $8M infusion

iCAD granted patent covering SecondLook Digital CAD solution incorporating lesion metrics

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