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Why Aren't Product Designers Considering Activity Trackers for Older Adults?

June 13, 2014 2:07 pm | by Human Factors and Ergonomics Society | News | Comments

Commercially available activity-monitoring apps, Web sites, and wearable devices allow for easy self-management of health and wellness. This technology may be particularly helpful for older adults, who can improve their cognitive function...

CDRH on Track to Improve Device Submission Review Process

June 13, 2014 2:00 pm | by Jeffrey Shuren, M.D., Director – Center for Devices and Radiological Health, FDA | Blogs | Comments

FDA’s Center for Devices and Radiological Health (CDRH) is committed to speeding innovative new medical devices to market and to improving the efficiency of our device submission review process. That’s critical for patients getting access...

Breaking Down the Regulation of LDTs: FDA Jurisdiction

June 13, 2014 1:54 pm | by Richard Park, Contributing Editor | Blogs | Comments

A couple of weeks ago, I reported on a letter that Bradley M. Thompson, JD, and James A. Boiani, JD, attorneys at Epstein Becker Green, recently sent to FDA Commissioner Margaret Hamburg. The attorneys sent this letter on behalf of the... 

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Manipulating and Detecting Ultrahigh Frequency Sound Waves

June 13, 2014 12:22 pm | by DOE/Lawrence Berkeley National Laboratory | News | Comments

An advance has been achieved towards next generation ultrasonic imaging with potentially 1,000 times higher resolution than today's medical ultrasounds. Researchers with the U.S. Department of Energy (DOE)'s Lawrence Berkeley National...  

First Biomarkers Found to Predict Severe Osteoarthritis

June 13, 2014 12:12 pm | by European League Against Rheumatism | News | Comments

The results of a study presented today at the European League Against Rheumatism Annual Congress (EULAR 2014) identify a correlation between the presence of biomarkers in the blood, known as micro RNAs (miRNAs), and the development of severe...

Imaging Tools Help Radiologists Diagnose Lung Cancer, Save Lives

June 13, 2014 12:02 pm | by Rochester Institute of Technology | News | Comments

Medical-imaging software under development at Rochester Institute of Technology could someday give radiologists a tool for measuring the growth of nodules in patients at risk of lung cancer, the leading cause of cancer deaths in the United...

New Test Detects Toxic Prions in Blood

June 13, 2014 11:50 am | by PLOS | News | Comments

The first cases of Mad Cow disease in humans (properly called variant Creutzfeld Jakob Disease, or vCJD) occurred in the late 1990s and are thought to be the consequence of eating contaminated beef products. Since then, several cases of...

Spectrum Health Among First to Implant Neurostimulator for Epilepsy

June 13, 2014 11:45 am | by Spectrum Health | News | Comments

Spectrum Health is the first health system in Michigan and among the first in the nation to successfully implant a recently FDA-approved device that uses electric stimulation of the brain to treat adult epilepsy patients whose seizures have...

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Lab Awarded $5.6 Million to Develop Next-Generation Neural Devices

June 13, 2014 11:38 am | by DOE/Lawrence Livermore National Laboratory | News | Comments

Lawrence Livermore National Laboratory recently received $5.6 million from the Department of Defense's Defense Advanced Research Projects Agency (DARPA) to develop an implantable neural interface with the ability to record and stimulate...

BIT Group Project Submission Wins 2014 Medical Design Excellence Award

June 13, 2014 11:28 am | by The Associated Press | News | Comments

BIT Group announces the DRG:HYBRID XL Analyzer has received the 2014 Medical Design Excellence Award (MDEA) for the category of In Vitro Diagnostics Products & Systems at the Medical Device & Manufacturing (MD&M) tradeshow in...

Medtronic Heart Valve Approved for Broader Use

June 13, 2014 11:14 am | by The Associated Press | News | Comments

Medtronic Inc. said Thursday that the FDA approved its artificial heart valve, CoreValve, for use in more patients who face serious risks from open-heart surgery, the standard treatment. Medtronic's implant is a less invasive approach to...

Blood Test Device Scoops Best in Show at MDEA 2014

June 13, 2014 9:54 am | by Atomo Diagnostics | News | Comments

The AtomoRapid blood testing platform can accommodate test strips for a wide variety of conditions from celiac disease, allergy through to infectious diseases such as malaria and HIV. The device delivers better clinical outcomes for patients...

mHealth Solution Wins Qualcomm QPrize

June 13, 2014 9:32 am | by PR Newswire | News | Comments

Qualcomm Incorporated, through its venture investment group, Qualcomm Ventures, has announced the winner of its fourth annual QPrize 2014 international seed investment competition, at Bloomberg's Next Big Thing Summit in Sausalito, California...

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FDA Releases First Phase of Global UDI Database

June 13, 2014 9:13 am | by FDA | News | Comments

First phase of the Global Unique Device Identification Database (GUDID): Guidance for Industry is now available. To quickly provide industry with information critical to successful use of the GUDID, we are issuing the GUDID Guidance in two...

Global IVD Market to Reach $74.65 Billion by 2020

June 13, 2014 9:07 am | by Allied Market Research | News | Comments

According to new research report by Allied Market Research titled "In Vitro Diagnostics Market (Techniques, Product Type, Usability, Applications, End-Users, Geography) - Industry Analysis, Trends, Share, Opportunities and Forecast, 2013...

Panel Provides Unanimous Favorable Recommendation to FDA for Bard's Drug Coated Balloon

June 12, 2014 8:28 pm | by The Associated Press | News | Comments

C. R. Bard, Inc. today announced that the U.S. Food and Drug Administration’s (FDA) Circulatory System Devices Advisory Panel provided a unanimous favorable recommendation to FDA for use of the Lutonix Drug Coated Balloon PTA Catheter (DCB)...

ulrich medical Releases New Spinal Implant for U.S. Market

June 12, 2014 5:29 pm | by The Associated Press | News | Comments

ulrich medical USA, Inc., has announced the U.S. market release of the uCentum Comprehensive Posterior System for open and minimally invasive (MIS) surgical approaches which is intended to provide immobilization and stabilization of spinal...

Rehab Helps Paralyzed Rats Learn to Grip Again

June 12, 2014 4:42 pm | by University of Zurich | News | Comments

After a large stroke, motor skills barely improve, even with rehabilitation. An experiment conducted on rats demonstrates that a course of therapy combining the stimulation of nerve fiber growth with drugs and motor training can be successful. The key, however, is the correct sequence: Paralyzed animals only ...

Compact Proton Therapy for Fight Against Cancer

June 12, 2014 4:33 pm | by HZDR | News | Comments

The future face of modern-day anti-cancer therapy based on charged particles like protons could potentially involve using laser accelerators. However, these facilities will need to be reduced in terms of both size and cost compared to conventional ones. In the scientific journal, "Applied Physics B" Dresden medical physicist Umar Masood is the first to ...

iHealth Launches World's Most Portable Mobile Blood Glucose Monitor

June 12, 2014 4:28 pm | by iHealth Lab | News | Comments

iHealth Lab has announced the launch of the iHealth Align, the world's smallest, FDA-approved mobile blood glucose monitor. The meter plugs directly into a smart phone and displays and stores readings using the iHealth Gluco-Smart app.  By displaying readings directly on ...

Collisions with Robots without the Risk of Injury

June 12, 2014 4:10 pm | by Fraunhofer | News | Comments

Teamwork between humans and robots will be the motto of the future. But robots may not injure humans at all. When does contact cause an injury, though? Researchers are exploring this for the first time in a study. Everybody has experienced ...

FDA Approves Bayer's Magnetic Resonance Contrast Agent

June 12, 2014 4:01 pm | by The Associated Press | News | Comments

Bayer HealthCare has announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Gadavist@  (gadobutrol) injection for intravenous use with MRI of the breast to assess the presence and extent of malignant breast  disease. The approval is ...

Implanted Infection Prevention

June 12, 2014 12:44 pm | by Fraunhofer | News | Comments

Hospital germs can be fatal, since they are resistant to antibiotics. As a result, alternative methods of defense against bacteria are in demand. Fortunately, a German-French research team has been able to develop bone implants that keep the germs at bay. The figures are alarming ...

A Picture's Worth a Thousand Words

June 12, 2014 12:39 pm | by Paul Hayes, JDRF | News | Comments

For nearly 100 years, we have known that type 1 diabetes (T1D) is a disease fundamentally about the progressive loss of insulin-producing beta cells, but measuring that loss has continued to elude researchers—at least until now. In a recent scientific publication, JDRF-funded researchers used a ...

Potential Anti-TNF Response Biomarker Identified

June 12, 2014 12:34 pm | by European League Against Rheumatism | News | Comments

DNA methylation has been identified as a potential biomarker of response to etanercept and adalimumab in patients with rheumatoid arthritis (RA) according to preliminary results from one of the largest methylome-wide investigations of treatment response to anti-TNF therapies. These data ...

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