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App-t Development for Next Generation Healthcare

April 16, 2014 | by Sean Fenske, Editor-in-Chief | Comments

I am a recent addition to the “smartphone revolution.” While I never doubted the usefulness of these devices, I was simply steadfast in holding out for a reduction in data rates. I figured that with more users adopting smartphones, eventually...

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FDA Works with China to Ensure Medical-Product Safety

April 18, 2014 8:02 am | by Christopher Hickey, Ph.D., Country Director for the People’s Republic of China, FDA | Comments

Americans benefit greatly from medical products produced by other countries. Approximately 40 percent of finished drugs in the United States come from overseas, as well as more than 50 percent of all medical devices. About 80 percent of the...

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Opportunities and Challenges of Doing Business in Companion Diagnostics

April 14, 2014 9:56 am | by Richard Park, Contributing Editor | Comments

For my occasional series of blogs examining various facets of the companion diagnostics market, I asked some of the major IVD manufacturers to share their thoughts and opinions on the current opportunities and challenges in companion...  

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HeartView Devices Addressing Cardiology Needs

April 11, 2014 2:45 pm | by Holly Ingram, Medical Devices and Healthcare IT Analyst, IHS Inc. | Comments

Aerotel has announced that their new ECG devices, the HeartView P12/8i and the HeartView 12L, have won CE Mark approval. In a mature market where the devices available to healthcare providers are already well equipped, manufacturers now...

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Patents Should Be Free in the U.S.A.

April 10, 2014 4:08 pm | by Peter Guckenheimer, Design Engineer | Comments

I have been a design engineer for over 50 years. During my time in Silicon Valley, I have had the good fortune to design a lot of solutions to difficult problems, offering simple, low-cost ideas. It was only when I worked at Hewlett Packard...

This ‘Electronic Skin’ Will Revolutionize Medicine

April 9, 2014 11:15 am | by Allegra Sparta, Contributor | Comments

It’s as thin as a temporary tattoo, but you definitely won’t get one in a cereal box. The creators of this “electronic skin” say that the technology could “one day aid patients with movement disorders or epilepsy.” It’s the first of its...

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Addressing Unmet Need for Real Innovation in Orthopedics

April 7, 2014 11:19 am | by Martha Shadan, President/CEO, Rotation Medical | Comments

Of all the musculoskeletal conditions that affect both professional and weekend athletes, complete tears of the rotator cuff tendon(s) remain one of the most significant therapeutic challenges to the orthopedic surgeon. Rotator cuff tears...

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Medicare Reimbursement for IVDs Gets an Upgrade

April 7, 2014 9:12 am | by Richard Park, Contributing Editor | Comments

Last Tuesday, President Obama signed into law the Protecting Access to Medicare Act of 2014 (H.R. 4302) that averted cuts to Medicare physician payments. (The Senate approved the bill the day before by a 64-35 vote, and the House of...   

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5 Takeaways from Conversations with Leading Providers at HIMSS

April 4, 2014 12:36 pm | by Lindsay Sanchez, Citrix | Comments

The HIMSS conference attracted 38,000 attendees and 1,200 exhibitors this year; an indication of the role HIT is predicted to play in healthcare transformation. However, the breadth of technologies displayed made you wonder how providers...

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It’s Better Being Bionic

April 4, 2014 12:29 pm | by Craig Lazenby, Press Officer, RSLSteeper | Comments

A ‘bionic man’ who was suicidal after losing his lower right arm in an industrial accident has declared that he would never go back to his ‘able bodied’ days. Nigel Ackland was one of the first people ever to be fitted with a Terminator-style...

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Virtual Reality, Telehealth, and the Future of Healthcare

April 3, 2014 2:04 pm | by Jay H. Sanders, M.D., Chief Wellness Officer, Remain Home Solutions | Comments

With Facebook’s acquisition of Oculus VR, the maker of the virtual reality headset Oculus Rift – and its implication for “virtual house calls” – the U.S. healthcare system seems poised to make a powerful shift toward the telehealth model...

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Polymer Solution Casting Thin Layering Process Overcomes Multilayer Tubing Challenges

April 2, 2014 2:47 pm | by Paul Schmeling, Director of Operations, Avalon Labs | Avalon Laboratories, LLC | Comments

Medical device manufacturers are demanding polymer tubing that offers increased functionality for market competitive demands while remaining cost-effective or reducing manufacturing costs. Co-extrusions or multilayer tubing is commonly used...

The Time and Place for RTLS Standardization

April 1, 2014 12:34 pm | by Andrew J. Mazotas, MS, PMP, Clinical Engineer, RTLS PMO, Veterans Health Administration | Comments

The far-reaching potential benefits of Real-Time Location Systems (RTLS) in healthcare are increasingly well understood and documented. Still, adoption of the technology among hospitals is not growing substantially. Might standardization...

FDA Wants Your Perspective on Clinical Trial Demographic Data

March 31, 2014 10:38 am | by Jonca Bull, M.D., Director of Office of Minority Health, FDA | Comments

When designing clinical trials, it is essential to test the safety and effectiveness of medical products in the people they are meant to treat. Although FDA’s policies, guidances, and regulations reflect decades of agency efforts to foster...

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Barriers to Companion Diagnostics: Market Sales and Clinical Utility

March 31, 2014 10:27 am | by Richard Park, Contributing Editor | Comments

The term companion diagnostic may be defined differently based on the perspective of the user. The term is sometimes used to refer to any IVD employed to select or modify use of a therapeutic agent. The definition for this blog reflects the...

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A Brief History Lesson on Obama and Companion Diagnostics

March 21, 2014 4:12 pm | by Richard Park, Contributing Editor | Comments

About eight years ago, a little known junior U.S. senator from a midwestern state introduced a bill called the Genomics and Personalized Medicine Act of 2006. In this bill, the senator proposed to increase funding for research on genomics...

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