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OpenFDA Provides Ready Access to Recall Data

July 17, 2014 3:01 pm | by Taha A. Kass-Hout, M.D., M.S., Chief Health Informatics Officer and Director of Office of Informatics and Technology Innovation, FDA | Comments

Every year, hundreds of foods, drugs, and medical devices are recalled from the market by manufacturers. These products may be labeled incorrectly or might pose health or safety issues. Most recalls are voluntary; in some cases they may be...

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Not Quite Rock Stars, But Ready to Take Center Stage

July 16, 2014 11:42 am | by Emily Cross, Ph.D., Director of Media and Communication, TecMed Inc. | Comments

My earlier posts have focused on issues relevant to the business side of TecMed Inc. that we thought were relevant to any medical device technology start-up. Friends and peers have mentioned that the articles have been easily pertinent to...

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Developing New Tools to Support Regulatory Use of “Next Gen Sequencing” Data

July 15, 2014 3:00 pm | by Carolyn A. Wilson, Ph.D., Associate Director for Research Center for Biologics Evaluation and Research, FDA | Comments

When you’re thirsty, you don’t want to take a drink from a fire hose. And when scientists are looking for data they don’t want to be knocked over with a flood of information that overwhelms their ability to analyze and make sense of it. That’s...

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Why Contraception by Remote Control Is a Troubling Idea

July 14, 2014 10:41 am | by Chris Warner, Executive Editor, ECN | Comments

Forget about remembering to take a contraceptive pill. In just a few years, keeping track of your remote control may be as essential to family planning as it is to watching TV. MicroCHIPS, a small, Massachusetts company with backing from Bill Gates...

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Merck Committed to Companion Diagnostics

July 11, 2014 4:27 pm | by Richard Park, Contributing Editor | Comments

During the past month and a half, pharmaceutical giant Merck has been actively forming partnerships with IVD manufacturers to develop companion diagnostics for their drugs. The following is a rundown of these recent alliances. At the end of...

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FDASIA at Year Two

July 10, 2014 9:33 am | by Margaret A. Hamburg, M.D., Commissioner, FDA | Comments

Anniversaries are a time for stock-taking and today, on the second anniversary of the Food and Drug Administration Safety and Innovation Act or FDASIA, I’m pleased to report on the progress we’ve made implementing this multi-faceted law. To...

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Applying the Data Distribution Service in an IoT Healthcare System

July 9, 2014 12:25 pm | by Angelo Corsaro, Ph.D., Chief Technology Officer, PrismTech | Comments

In my last post, I described how the Data Distribution Service (DDS) standard is used to provide ubiquitous access to clinical measurements. In this post, I will be introducing the foundations of this enabling technology that can allow healthcare...

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Getting Started with Your Idea for a Medical Device

July 7, 2014 5:04 pm | by David Foshee, Principal Design Engineer, Gilero LLC | Gilero, LLC | Comments

As a medical device design and development consultancy, Gilero has worked with a number of clients who have conceived of an idea for a new medical device on their own, and are interested in learning how to bring their concept to market... 

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Breaking Down the Regulation of LDTs: Public Health, First Amendment, and Innovation

July 7, 2014 11:52 am | by Richard Park, Contributing Editor | Comments

According to the letter, for the past 38 years, the FDAs of seven Presidential administrations have failed to confront the problem of the existence of dual regulatory systems for IVDs and LDTs. To compensate for this, the agency has attempted...

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Empowering Consumers Through Accurate Genomic Tests

July 2, 2014 11:45 am | by Jeffrey Shuren, M.D., Director – Center for Devices and Radiological Health, FDA | Comments

We’ve come to recognize that almost every disease has a genetic component, and many consumers now are eager to know more about their genetic profiles. They need only send a sample of their DNA collected from their saliva or from a cheek swab...

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Are Your Compliance Practices Cloud and Mobile Friendly?

July 1, 2014 3:23 pm | by Mika Javanainen, Senior Director of Product Management, M-Files Corporation | Comments

The “bring your own device” (BYOD)-enabled workforce is altering the landscape of compliance-related content management. Medical device companies should take this trend seriously because if you implement your BYOD strategy well, it can have...

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Six Steps That Optimize Your Medical Device for Manufacture

June 30, 2014 2:55 pm | by Mark Drlik, Mechanical Engineer and Project Manager, StarFish Medical | Comments

Many medical device manufacturing pitfalls come with the territory. Physical architecture, vendor selection, and even basic details like specifying the labels and fasteners on a part can raise costs or lower reliability. Follow the six steps...

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Trends and Developments in the European Companion Diagnostics Market

June 27, 2014 4:04 pm | by Richard Park, Contributing Editor | Comments

Frost & Sullivan recently released a report entitled, “Western European Companion Diagnostics Market.” This study provides a global outlook of the companion diagnostics market, specifically focusing on Western Europe. The report discusses...

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Filling Information Gaps for Women in Medical Device Clinical Trials

June 27, 2014 1:58 pm | by David Strauss, M.D., Ph.D., Medical Officer, Center for Devices and Radiological Health, FDA | Comments

At FDA’s Center for Devices and Radiological Health (CDRH), results from clinical trials often serve as the foundation for our decisions to approve the most important medical devices — devices, such as implantable heart devices, that carry...

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What the Medical Industry Can Learn from the Aerospace Industry

June 26, 2014 12:08 pm | by Bob Hill, President, Solar Atmospheres | Comments

Heat treatment standards are stricter in the aerospace industry than in the medical industry where lives are on the line. This doesn’t make sense and something is being done about it. Recently, I was asked to give a vacuum heat treating...

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