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Data Presented on the Oncotype DX Test and Precision Oncology

September 29, 2014 10:05 am | by The Associated Press | News | Comments

In line with this year’s theme for the annual European Society for Medical Oncology (ESMO) Congress - ‘Precision Medicine in Cancer Care’ - Genomic Health presented results from multiple studies across different cancer types demonstrating how...

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Examining the Physician Office Lab Market: CLIA and Technology

September 29, 2014 9:21 am | by Richard Park, Contributing Editor | Blogs | Comments

Kalorama Information recently released a report entitled, “Physician Office Laboratory Markets, 3rd Edition,” which provides a complete review of this important segment of the IVD industry. The following presents some of the report’s analyses...

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FDA Finalized Guidance 510(k) and New Draft Guidance

September 29, 2014 8:30 am | by Jonathan S. Kahan, partner, John J. Smith, partner, Jennifer A. Henderson, counsel, Danielle C. Woodlee, associate; Hogan Lovells | Articles | Comments

On July 28, 2014, the U.S. Food and Drug Administration (FDA) finalized its guidance, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (Final Guidance), the draft version of which was released...

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Intellectual Property for Competitive Advantage

September 29, 2014 8:30 am | by John Whynott, Technical Product Manager, Mikrotech | Mikrotech | Blogs | Comments

It is important and will always remain important. Most medical devices manufacturers have difficulty sustaining leadership in all areas of manufacturing (vertical integration). A more cost-effective approach is to outsource areas they have...

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Ready to Ship Circuit Board Shields

September 29, 2014 8:30 am | by MDT Staff | Leader Tech Inc. | Product Releases | Comments

Many electronics manufacturers are burdened with seemingly impossible time-to-market and material sourcing demands. To help alleviate this immense pressure, Leader Tech introduces a large selection of Quick Ship board level shields that are ready...

Pocket-Size Bluetooth 2-D Barcode Scanner

September 29, 2014 8:30 am | by MDT Staff | Denso Robotics | Product Releases | Comments

DENSO ADC, the Americas sales arm of DENSO Wave Incorporated, inventor of the QR Code, announced a new SE1-QB Bluetooth wireless 2-D barcode scanner. The lightweight yet durably built SE1-QB measures only 3.9 inches long, 1.6 inches wide and 1.1...

CE Mark for ReFlow Medical’s Wingman35 Crossing Catheter and SpeX Shapeable Support Catheter

September 26, 2014 4:00 pm | by Business Wire | News | Comments

ReFlow Medical, Inc. (ReFlow) has announced the initial clinical use of their Wingman35 Crossing Catheter and speX Shapeable Support Catheter by Dr. Andrej Schmidt at University Leipzig, Germany. The devices were recently granted European...

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Heart Hospital of Austin First in Texas To Offer New Heart Failure Monitoring System

September 26, 2014 3:46 pm | by PR Newswire | News | Comments

On Sept. 24, 2014, Heart Hospital of Austin became the first facility in Texas to implant a new miniaturized, wireless monitoring sensor to manage heart failure (HF). The CardioMEMS HF System is the first and only FDA-approved heart failure...

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New Tool Assesses Skill Development in Robotic Microsurgery

September 26, 2014 3:32 pm | by Wolters Kluwer Health | News | Comments

A new standardized assessment provides a useful tool for tracking surgeons' progress as they develop the skills needed to perform robot-assisted microsurgery, reports a study in the October issue of Plastic and Reconstructive Surgery, the official...

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COPD Patients Breathe Easier with Lung Flute

September 26, 2014 2:55 pm | by University at Buffalo | News | Comments

Patients with chronic obstructive pulmonary disease (COPD) report improved symptoms and health status when they use a hand-held respiratory device called the Lung Flute®, according to a new study by the University at Buffalo. Usually caused by...

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FDA Clearance on Beckman Coulter’s Power Express Automated Sample Processing System

September 26, 2014 2:22 pm | by Beckman Coulter | News | Comments

Delivering on its commitment to help labs face new challenges in the ever-changing healthcare environment, Beckman Coulter has received U.S. Food and Drug Administration (FDA) 510(k) clearance on its Power Express high-speed automated sample...

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New Technology May Lead to Prolonged Power in Mobile Devices

September 26, 2014 11:57 am | by The University of Texas at Dallas | News | Comments

Researchers from The University of Texas at Dallas have created technology that could be the first step toward wearable computers with self-contained power sources or, more immediately, a smartphone that doesn’t die after a few hours of heavy...

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With NIH Grant, Cedars-Sinai Helps Bring Big Data to Neuro Disease Research

September 26, 2014 11:00 am | by Cedars-Sinai Medical Center | News | Comments

Investigators at the Cedars-Sinai Board of Governors Regenerative Medicine Institute have received a grant from the National Institutes of Health to participate in a consortium taking the study of motor neuron disorders – such as Lou Gehrig's...

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MDPC Publishes Robust Security Risk Assessment Framework for Medical Devices

September 26, 2014 10:56 am | by Medical Device Privacy Consortium | News | Comments

The Medical Device Privacy Consortium's Product Security Working Group has developed a robust framework for medical device manufactures and developers to assess the security risks associated with the use of medical devices. The framework is...

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Virginia Tech Joins $30 Million Effort to Curb Head Injuries

September 26, 2014 10:46 am | by Virginia Tech | News | Comments

Virginia Tech is participating in a new, landmark $30 million national effort sponsored by the National Collegiate Athletic Association and the U.S. Department of Defense to combat concussions among college athletes and active service military...

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