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Design Innovation vs. The ‘What If?’

August 22, 2014 | by Sean Fenske, Editor-In-Chief | Comments

There are many obstacles to a successful product design getting into the marketplace (in the medical device space, some would argue that the FDA needlessly creates even more, however, that’s for another day’s discussion). Therefore, designers...

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Experts: 90% of Medical Records Are Vulnerable to Hackers

August 21, 2014 3:18 pm | by A.J. Watts, ECN Editorial Intern | Comments

Many tech-savvy people take major precautions to guard themselves against hackers by encrypting their personal data and protecting their Wi-Fi at home. Sadly, hospitals and clinics haven’t taken those same precautions and are under attack...

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Clinical Trials: Enhancing Data Quality, Encouraging Participation and Improving Transparency

August 20, 2014 2:03 pm | by Margaret A. Hamburg, M.D., Commissioner, FDA | Comments

Today FDA is announcing important steps that the agency plans to take to enhance the collection and availability of clinical trial data on demographic subgroups – patient populations divided by sex, race/ethnicity or age. Section 907 of the...

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Providing Easy Access to Medical Device Reports Submitted to FDA Since the Early 1990s

August 19, 2014 2:06 pm | by Taha A. Kass-Hout, M.D., M.S., Chief Health Informatics Officer and Director of Office of Informatics and Technology Innovation, FDA and Jeffrey Shuren, M.D., Director – CDRH, FDA | Comments

In addition to food and drugs, FDA has regulatory oversight of tens of thousands of medical devices ranging from bandages and prosthetics to heart valves and robotics. These products are used by millions of Americans, and they are essential...

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Payment Policy Challenges for Companion Diagnostics

August 18, 2014 9:26 am | by Richard Park, Contributing Editor | Comments

The Personalized Medicine Coalition (PMC; Washington, DC) recently released a report calling for critical changes in payment and coverage policies for companion diagnostics, which would encourage innovation and improve the quality of healthcare...

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“Life was short, disgusting and painful” - CE Aretaeus of Cappadocia

August 14, 2014 9:46 am | by Emily L. Cross, Ph.D., TecMed, Inc. | Comments

It is easy to make the assumption that modern medical tools answer to the demands Diabetes Mellitus puts on patients in both surgical and critical care environments. Additionally, it is easy to think that the tools used to measure blood glucose levels to manage day-to-day health are both advanced and accurate. It is true what is available has saved millions of lives, yet, the tools we depend on for survival are almost as archaic as ...

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Now Begins the Fight Over LDT Regulations

August 12, 2014 8:46 am | by Richard Park, Contributing Editor | Comments

As IVD manufacturers and clinical laboratories gathered at the American Association for Clinical Chemistry's (AACC) annual meeting and clinical lab expo in Chicago, FDA made a major announcement that will likely test the relationship between...

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In technology we trust

August 11, 2014 3:11 pm | by David Mantey, Editor in Chief, ECN | Comments

Within twenty years, hands-free driving will be a reality. The prediction (at least for freeway driving), from Jim Toal, senior manager of product marketing, Vishay Optoelectronics has me in a state of skeptical excitement. While I'm ready for the day when I can hit "Home" ...

5 Steps that Speed EMC Testing

August 7, 2014 2:13 pm | by Bjarne Hansen, Electrical Engineer, StarFish Medical | Comments

Electromagnetic interference (EMI) refers to unwanted effects in a medical device due to electromagnetic energy present in the environment. EMI can prevent proper operation of a medical device. For example, certain electric wheelchairs and...

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Will Medical Devices and All-Laser Manufacturing Advancements Enable the Age of Longevity?

August 6, 2014 2:45 pm | by Stefan Zschiegner, Raydiance | Comments

Perhaps the only advances in medical technology which excite more than today’s minimally invasive devices and procedures are the ones that will come to market over the next several decades. Medical futurists speak with credibility about the...

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UDI: A Nonstandardized Test for Manufacturers

August 5, 2014 4:23 pm | by Karen Conway, Executive Director, Industry Relations, GHX | Comments

The underlying purpose of the U.S. FDA’s Unique Device Identification (UDI) Rule seems simple enough: to “adequately identify medical devices through distribution and use.” But even manufacturers that have been working for years – some even...

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Curbing Risk, Not Medical Innovation, in Personalized Medicine

August 4, 2014 3:55 pm | by Jeffrey Shuren, M.D., Director – Center for Devices and Radiological Health, FDA | Comments

Innovative new tests are routinely submitted to the Food and Drug Administration to assure they are safe and effective. They include genetic tests that help oncologists decide whether a patient is a good candidate for a drug that treats melanoma...

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Breaking Down the Regulation of LDTs: Moving Forward

August 4, 2014 3:29 pm | by Richard Park, Contributing Editor | Comments

The letter stated that in order to move toward equal regulation, FDA should share its thinking on what it believes LDT regulation under FDCA should look like in practice, or how it plans to deregulate IVDs, by releasing its draft guidance...

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This first-aid kit is a must-have

July 31, 2014 11:11 am | by Kasey Panetta, Managing Editor, ECN | Comments

The Clever Medkit is a first-aid kit to end all first-aid kits. This over-the-top technologically advanced kit is technically designed for businesses, but I would consider this for a home purchase because I am a germaphobe and hypochondriac. (Yesterday, I used a Lysol wipe on my pens.) So, let's walk through the process of injuring yourself and using this bad boy.

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Eight Areas That Can Make or Break Your Medical Device Success

July 30, 2014 6:57 pm | by Vincent Crabtree, PhD, StarFish Medical | Comments

Identifying areas of greatest weakness is an important sanity check that will pay off while raising funds, clearing regulatory approval, and accessing the market for a new medical device. The eight areas described below can make or break your medical device success.

The LDT Letter Battle

July 28, 2014 9:30 am | by Richard Park, Contributing Editor | Comments

Earlier this month, five democratic U.S. Senators sent a letter to the Office of Management and Budget (OMB) regarding the regulation of laboratory-developed tests (LDT). In this letter, Senators Edward J. Markey (D-MA), Richard Blumenthal...

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