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True 3D Images...Glasses-Free

February 27, 2015 | by Sam Brusco, Associate Editor, @SamISureAm | Comments

3D Icon’s imaging technology is poised to profoundly impact medical device development as well as healthcare practices. An upgrade on existing 3D imaging systems, “CSpace” provides an incredibly realistic display that you might as well be...

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The Global Brainstorm: Solutions to Neurodegenerative Diseases

March 2, 2015 11:40 am | by Miri Polachek, Executive Director, Israel Brain Technologies | Comments

As medical treatment improves dramatically, allowing us to live longer lives, neurodegenerative diseases such as Alzheimer’s disease and Parkinson’s are becoming increasingly prevalent. Close to 40 million people suffer from Alzheimer’s...

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Rare Diseases at FDA: A Successful Year for Orphan Products

February 28, 2015 8:30 am | by Gayatri R. Rao, M.D., J.D. | Comments

2014 was a strong year for rare disease product development at FDA. It was also a year of significant firsts. In recognition of Rare Disease Day, February 28th, we want to reflect on the progress we have made thus far as we renew our commitment...

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Why This Student Became a Biomedical Engineer Instead of a Doctor

February 27, 2015 8:30 am | by Kasey Panetta, Editor, ECN, @kcpanetta | Comments

My PhD project develops a novel methodology to test the performance of bone and cartilage substitutions in a natural knee joint using a knee simulator. It can be used for the pre-clinical testing of tissue substitutions or for investigating...

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Focus Growing to Detect Deterioration in Patient Status

February 26, 2015 8:30 am | by Kelly Patrick, Associate Director, Clinical Care Devices, IHS Medical Technology | Comments

With increasing focus to improve patient outcomes and reduce costs, the importance of continuously monitoring patients throughout their treatment pathway in the hospital is growing. Continuous monitoring is not only demanded in high-acuity...

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Bacterial Infections Associated with Duodenoscopes: FDA’s Actions to Better Understand the Problem and What Can be Done to Mitigate It

February 25, 2015 2:16 pm | by William Maisel, M.D., M.P.H. | Comments

Duodenoscopes are flexible, lighted tubes that are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum). Duodenoscopes are used in more than 500,000 procedures, called endoscopic retrograde cholangiopancreatography...

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Oral Sensors Are No Longer Science Fiction

February 25, 2015 8:30 am | by Charles Settles, Product Analyst, TechnologyAdvice | Comments

Oral implantation of “microchips” has long been a focus of conspiracy theorists, but advances in both miniaturization and medical software mean this oft-ridiculed concept is quickly becoming reality. Almost every dentist that’s...

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Moving Toward a National Medical Device Postmarket Surveillance System

February 25, 2015 8:30 am | by Jeffrey Shuren, M.D., J.D. and Thomas P. Gross, M.D., MPH | Comments

Despite rigorous premarket evaluation, what really counts is how well a medical device works when it’s used day-to-day by patients, caregivers and clinicians. Beyond clinical trials, real-life patient experience may reveal unanticipated...

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Looking Ahead In the Wake of CES Device Reclassification

February 24, 2015 8:30 am | by Mike Fegley, Electromedical Products International | Comments

In June, the Food and Drug Administration (FDA) announced its intention to reclassify cranial electrotherapy stimulation (CES) devices from a class III to a class II designation, ending a battle that the CES industry has fought with the...

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Embedded Technology: The Vital Organ of Wireless and Connected Health

February 24, 2015 8:30 am | by Chris Ault, Senior Product Manager, QNX Software Systems | Comments

The advent of smartphones and other mobile devices has given us a daily mechanism to share and access information on an unprecedented level. Consider how a smartphone can transform the simple ritual of getting a caffeine fix. An integrated...

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An Alarming Problem with Medical Technology

February 23, 2015 2:33 pm | by Sean Fenske, Editor-in-Chief, @SeanFenske | Comments

During my recent visit to ECRI to hear more about their watch list for safety innovations in healthcare, the topic of alarm fatigue was brought up. In fact, it’s an item that comes up quite often at ECRI in terms of their hazards lists [#1 concern on the list for the past four years (check out the...

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Making Things Smaller Is Wonderful for the Patient

February 21, 2015 8:30 am | by Kate Pereira, Senior Project Manager, Ximedica | Ximedica | Comments

Much of the focus of implants to date has been in vascular and circulatory. I think more time will start to be placed in the other systems – neural, musculature, and lymphatic. It all comes back to the driver of making the patient feel as...

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Monitoring Fitness...in the Bedroom

February 20, 2015 2:02 pm | by Sam Brusco, Associate Editor, @SamISureAm | Comments

Spanish smartphone maker Geeksphone is introducing a functionality that will really get your heart racing into its soon-to-be released wearable fitness tracker, GeeksMe. It’s basically a traditional fitness monitor, including a step counter...

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Cortical Modem Implant Promises Cyborg Vision

February 20, 2015 1:52 pm | by Meaghan Ziemba, Editor, WDD, @MZiembaWDD | Comments

DARPA is taking wearable technology to the next level with its recent cortical modem concept. This tiny implant plugs into users’ DNA and visual cortex to help cure vision loss by exhibiting a heads-up display in front of their eyes. What makes...

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Improved Implantable Technologies to Combat Chronic Degenerative Diseases

February 20, 2015 8:30 am | by Mark Russell, Senior Global Market Manager, Medical Electronics, Bal Seal Engineering, Inc. | Comments

Implantable devices—especially those for cardiac and neuro applications—are among the most significant medical innovations in the last 20 years. As the population has continued to age, elderly patients find themselves faced with chronic...

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The Phrase 'Long-Term Implant' is a Moving Target

February 20, 2015 8:30 am | by Mark Geiger, VP, Sales and Marketing, Interface Catheter Solutions | Interface Catheter Solutions | Comments

Our kids will live until they’re 100 years old. That’s a fact. Forever is becoming a long time so the phrase “long-term implant” is a moving target. Some implants with moving parts require millions of cycles to simulate physiologic norms...

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