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How to Market Your Device

June 16, 2014 9:34 am | by U.S. Food & Drug Administration | News | Comments

Medical devices marketed in the United States are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299... 

Sequenom, Inc. Receives U.S. FDA Premarket Clearance

June 16, 2014 8:28 am | by PR Newswire | News | Comments

Sequenom, Inc., a life sciences company providing innovative genetic analysis solutions, announced today that it has received premarket 510(k) clearance from the United States Food and Drug Administration (FDA) to market its IMPACT Dx Factor...

Nanoscale Composites Improve MRI

June 13, 2014 2:41 pm | by Mike Williams, Rice University | News | Comments

Submicroscopic particles that contain even smaller particles of iron oxide could make magnetic resonance imaging (MRI) a far more powerful tool to detect and fight disease. Scientists at Rice University and The Methodist Hospital Research...

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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... 

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...

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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...

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...

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...

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 ...

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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Agreement for Commercializing Previstage GCC Colorectal Cancer Staging Test in China

June 11, 2014 4:46 pm | by Shuwen Biotech | News | Comments

Shuwen Biotech, a diagnostic company focused on licensing, developing and commercializing diagnostic kits and services for unmet clinical needs in China, has announced that it has formed an alliance with the Canada-based DiagnoCure to commercialize the Previstage™ GCC colorectal cancer staging test ...

UCL Licences Research to Collagen Solutions for Next Generation Collagen Products

June 11, 2014 12:50 pm | by Henry Rummins, University College London | News | Comments

UCL Business, the wholly-owned technology transfer company of UCL, has concluded an exclusive licencing agreement with Collagen Solutions – the developer and manufacturer of medical grade collagen components for use in regenerative medicine, medical devices and ...

Tiny Sensor Tests the Chemical Composition of Liquids

June 11, 2014 12:41 pm | by Florian Aigner, Vienna University of Technology | News | Comments

They are invisible, but perfectly suited for analysing liquids and gases; infrared laser beams are absorbed differently by different molecules. This effect can for instance be used to measure the oxygen concentration in blood. At the Vienna University of Technology, this technique has ...

A Few Circulating Cancer Cells Could Cue Risk of Metastases

June 10, 2014 4:14 pm | by Kimberly Brown, Society of Nuclear Medicine | News | Comments

A simple noninvasive blood test matched with state-of-the-art molecular imaging of individual cells could help oncologists understand their patients' chances of survival, say researchers at the ...          

Toshiba Introduces New Patient-Friendly PET/CT System

June 10, 2014 3:57 pm | by Toshiba | News | Comments

Oncology departments can now provide their patients with a better PET/CT imaging experience using Toshiba America Medical Systems, Inc.’s all-new Celesteion (pending 510(k) clearance). The versatile system combines ...      

Photos of the Day: Monitoring Vitals with Light

June 10, 2014 12:41 pm | by The Optical Society | News | Comments

In a pair of papers published in The Optical Society's (OSA) open-access journal Biomedical Optics Express, groups of researchers from the Netherlands and Israel describe two new wearable devices that use changing patterns of scattered light to ...

Biometric Watches Use Light to Non-Invasively Monitor Patients

June 10, 2014 12:35 pm | by Angela Stark, The Optical Society | News | Comments

Monitoring a patient's vital signs and other physiological parameters is a standard part of medical care, but, increasingly, health and fitness-minded individuals are looking for ways to easily keep their own tabs on ...    

Gyroscopes Can Help Diagnose ADHD

June 10, 2014 12:09 pm | by Institute of Physics and Engineering in Medicine | News | Comments

Recent advances in technology have led to affordable, miniature, inertial sensors that incorporate both accelerometers and gyroscopes. This enables a device no bigger than a wristwatch to measure a wide range of movements, such as tilting, rotation, acceleration, and ...

FDA Clearance for Newest Model of WatchPAT Device

June 9, 2014 10:28 am | by The Associated Press | News | Comments

Itamar Medical reported that the new and upgraded model of the WatchPAT, Itamar Medical's leading sleep apnea diagnostic device, has been cleared by the FDA. The FDA clearance came earlier than anticipated, and was announced at the Annual...

Why Bother? Is the Fight Really Worth It?

June 9, 2014 10:17 am | by Emily L. Cross, Ph.D., Director of Media and Communication, TecMed Inc. | Blogs | Comments

In some eyes, TecMed, Inc. might be considered the world’s longest standing medical ‘start-up.’ Even CEO Alan Leszinske claims that the name ‘start-up’ might be a bit erroneous since the company has been in full swing for nearly 2 decades...

Fully Automated DNA Lab-on-a-Chip Microfluidic System Wins Competition

June 9, 2014 10:03 am | by Dolomite | The Dolomite Centre Ltd | News | Comments

Dolomite have announced the winner of their 2013 Productizing Science competition as Molbot Pte. Ltd. The company submitted the concept of a low-cost bench-top molecular biology “Minilab” for automating molecular biology applications...  

New Molecule Enables Quick Drug Monitoring

June 9, 2014 9:31 am | by Ecole Polytechnique Fédérale de Lausanne | News | Comments

Monitoring the drug concentration in patients is critical for effective treatment, especially in cases of cancer, heart disease, epilepsy and immunosuppression after organ transplants. However, current methods are expensive, time-consuming...

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