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The Lead

First FDA-Approved Stool DNA Screening Test Gains Support

November 26, 2014 12:14 pm | by Exact Sciences Corp. | News | Comments

Exact Sciences Corp. announced that the Centers for Medicare & Medicaid Services has issued its final payment decision regarding Cologuard and will reimburse it at $502 per test. Cologuard is the first and only FDA-approved noninvasive stool...

A MedTech Thanksgiving Tale

November 26, 2014 8:30 am | by Sean Fenske, Editor-in-Chief | Blogs | Comments

Not so long ago, the collective nations of the medtech Native Americans co-existed in relative...

Prepping for the Next Major Epidemic

November 24, 2014 12:09 pm | by Lauran Neergaard, AP Medical Writer | News | Comments

The next Ebola or the next SARS. Maybe even the next HIV. Even before the Ebola epidemic in West...

IBM Wants a DNA Reader in Every Doctor’s Office

November 24, 2014 11:26 am | by Arizona State University | News | Comments

A team of scientists from Arizona State University's Biodesign Institute and IBM's T.J. Watson...

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A Genetic Test for Endometriosis

November 24, 2014 11:17 am | by University of California - San Francisco | News | Comments

Researchers at UC San Francisco have identified patterns of genetic activity that can be used to diagnose endometriosis and its severity, a finding that may offer millions of women an alternative to surgery through a simple noninvasive procedure...

WHO: Ebola IVDs Urgently Needed

November 24, 2014 9:00 am | by Richard Park, Contributing Editor | Blogs | Comments

Last week, the World Health Organization (WHO) released an assessment of the Ebola virus situation. In its assessment, WHO stressed that IVDs for Ebola are “urgently needed.” “The goal of interrupting chains of Ebola virus transmission depends...

Cancer Biomarker and Drug Delivery System in One

November 21, 2014 11:48 am | by Nanyang Technological University | News | Comments

Nanyang Technological University in Singapore (NTU Singapore) has invented a unique biomarker with two exceptional functions. First, it lights up when it detects tumor cells to allow scientists to take a better look. And it can also release anti-cancer...

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Genetic Test for Eye Disorders Proves Very Effective

November 21, 2014 11:19 am | by Massachusetts Eye and Ear Infirmary | News | Comments

Investigators at Massachusetts Eye and Ear and Harvard Medical School Department of Ophthalmology and colleagues reported the development and characterization of a comprehensive genetic test for inherited eye disorders in the online version of...

Friday 5: Don Labriola of QuickSilver Controls Speaks on Automated Healthcare

November 21, 2014 10:23 am | by Sean Fenske, Editor-in-Chief | Blogs | Comments

According to Labriola, he “grew up” at Beckman (now under Danaher), starting with the company at age 17 and worked there for the next 20 years of his career. Most of his time was spent in the Medical Diagnostics Group. “I worked on the electronics...

Converging Medical Device, Drug, and Biotech Companies

November 21, 2014 7:30 am | by Michael Drues, Founder & President, Vascular Sciences | Blogs | Comments

Most device development is evolutionary, (i.e., come out with one device, tweak it a bit to make a new device, etc.) I understand the advantages of evolutionary device development from a technology perspective, from a business perspective...

Top 10 from Medica & CompaMed

November 20, 2014 2:37 pm | by John Dipierro, Multimedia Production Specialist | Videos | Comments

Welcome to MDT’s Top 10 list from the Medica and Compamed shows, which took place in Dusseldorf, Germany. This was my first visit to the event, so to say it was overwhelming, yet fantastic, would be an understatement. Watch my list of the ten best things I saw.

Computer Model to Better Understand Gastrointestinal Disease

November 20, 2014 10:47 am | by Tufts University | News | Comments

Tufts University School of Engineering researchers and collaborators from Texas A&M University have published the first research to use computational modeling to predict and identify the metabolic products of gastrointestinal tract microorganisms...

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Handheld Ultrasounds Improve Physical Diagnosis

November 20, 2014 10:30 am | by The Mount Sinai Hospital | News | Comments

A new study by researchers from Icahn School of Medicine at Mount Sinai found that training medical students to use a handheld ultrasound device can enhance the accuracy of their physical diagnosis. The study was presented November 18 at the American...

Working More Closely With Hospital Systems and Payers

November 20, 2014 7:30 am | by Michael Pereira, Senior Vice President of Technology & Operations, Ximedica | Ximedica | Blogs | Comments

Innovations are occurring from multiple paths, all fueled from a consumerization of the medical industry. Our expectations as patients, or as clinicians, or even as payers are changing what is acceptable coming from the medical device industry...

Maintenance-Free Clinic Box for Clinical Monitoring Processes

November 19, 2014 7:17 pm | by Kontron America Inc. | Kontron America, Inc. | Product Releases | Comments

Kontron, a leading supplier of embedded computing technology, introduces the new Clinic-BPC B-101 for clinical processes. The system was developed specifically for applications in the medical environment, in particular for use close to patients. The PC stands out thanks to easy...

Making the Case for Reusable Custom Cases

November 19, 2014 5:11 pm | by Tim Jennings, CEO, EPS | Articles | Comments

Customized cases provide medical device manufacturers and health care professionals with durable, sustainable and secure options for the transport, storage, and end use of expensive medical equipment. Available in countless configurations...

MIT Student Hacks Health Care

November 19, 2014 4:03 pm | by Massachusetts Institute of Technology | News | Comments

For as long as she can remember, Andrea Ippolito has known that she wanted to be an engineer. What she couldn’t have predicted was what, precisely, the scope and scale of her work would turn out to be. Ippolito began her career at Boston Scientific...

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Making Health Care More Accessible with Flexible Electronics

November 19, 2014 3:25 pm | by American Chemical Society | News | Comments

Flexible electronic sensors based on paper -- an inexpensive material -- have the potential to some day cut the price of a wide range of medical tools, from helpful robots to diagnostic tests. Scientists have now developed a fast, low-cost way of making these...

Preventing and Reducing Hospital Admissions

November 19, 2014 7:30 am | by Marc Dubreuil, Vice President of Business Development, Farm Design | Blogs | Comments

We are beginning to see more integration of capabilities in order to provide imaging, diagnostics, and tissue manipulation within a single device and procedure. This allows the clinician, after confirming suspicious tissue, to biopsy, ablate...

Blood Test Warns of Kidney Transplant Rejection

November 18, 2014 3:22 pm | by IDIBELL-Bellvitge Biomedical Research Institute | News | Comments

Researchers at the Bellvitge Biomedical Research Institute (IDIBELL) and doctors at University Hospital of Bellvitge, together with a team of researchers from the University of California, Cincinnati Children's Hospital, California Pacific Medical...

Technology ‘Lights Up’ Cancer in the Blood

November 18, 2014 2:57 pm | by Northwestern University | News | Comments

Metastasis is bad news for cancer patients. Northwestern University scientists now have demonstrated a simple but powerful tool that can detect live cancer cells in the bloodstream, potentially long before the cells could settle somewhere in...

Magnetic Micro-Actuators Could Serve as a Transport Mechanism Within the Body

November 18, 2014 2:15 pm | by ETH Zurich | News | Comments

Scientists have been conducting research on micrometer-sized actuators which one day may make it possible to transport drugs or chemical sensor molecules to specific locations throughout the human body. Researchers at ETH Zurich have now taken...

Analyst: Debate Over Device Tax Only Masks Needed Reforms

November 18, 2014 12:04 pm | by GlobalData | News | Comments

Rob Littlefield, MSc, GlobalData’s Analyst covering Medical Devices, says, “Republicans in the US Congress are expected to move quickly to revoke the medical device tax, which was imposed two years ago as part of a suite of fees on the healthcare...

Sharing Personal Health Data: The Patient’s Opinion

November 18, 2014 11:48 am | by Team Consulting | News | Comments

In a survey of 2,000 patients suffering from chronic medical conditions (such as diabetes, cancer, asthma, COPD and arthritis) less than 4% of respondents were happy to share their personal health data with consumer companies such as Nike, Apple...

MEDICA and COMPAMED Post-Show Wrap-Up

November 18, 2014 11:26 am | by Messe Düsseldorf | News | Comments

“The high number of international visitors gave medical device technology providers as well as their suppliers at MEDICA and COMPAMED tailwinds to strengthen their export business. Those putting their business on a particularly broad footing...

Assessing the Good and the Bad in the LDT Guidances

November 17, 2014 2:35 pm | by Richard Park, Contributing Editor | Blogs | Comments

FDA recently released two draft guidances on the regulation of laboratory-developed tests (LDT): Framework for Regulatory Oversight of LDTs and FDA Notification and Medical Device Reporting for LDTs. With the release of these guidances, the agency...

Genetic Test Steers Cancer Treatment

November 17, 2014 11:57 am | by Dana-Farber Cancer Institute | News | Comments

For patients with aggressive types of leukemia and other blood cancers, quickly identifying and starting the right treatment can make all the difference. In a major advance in the care of these patients, physicians at Dana-Farber/Brigham and...

University to Develop Portable Device to Diagnose Ebola

November 17, 2014 11:36 am | by University of Westminster | News | Comments

The University of Westminster has been awarded a research grant of £620,000 funded by The Department for International Development (DFID) and the Wellcome Trust to develop a portable device which can test bodily fluids to diagnose the Ebola virus...

90-Minute Test Detects Infection in Only Milliliters of Blood

November 17, 2014 10:34 am | by University of California - Irvine | News | Comments

A new bloodstream infection test created by UC Irvine researchers can speed up diagnosis times with unprecedented accuracy, allowing physicians to treat patients with potentially deadly ailments more promptly and effectively. The UCI team, led...

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