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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 been practicing...

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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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Smartphone Apps Aren't Doctors

February 24, 2015 3:19 pm | by Sam Brusco, Associate Editor, @SamISureAm | Comments

Something a smartphone can never accomplish is acquiring a medical degree. (Yet, as those who live in the constant fear of a robot uprising will say.) The so-called “melanoma diagnostic apps” MelApp and Mole Detective have learned this...

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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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MedTech’s Patient-Centric Trajectory Is Fueled by Technology

February 20, 2015 8:25 am | by Sean Fenske, Editor-in-Chief, @SeanFenske | Proto Labs, Inc. | Comments

There is little doubt we are on a patient-centric trajectory that is fueled by technology. Can regulation keep up with the changing environment? Herein lies the challenge. To accelerate innovation and speed to market, I see an increased...

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Need to Maintain Balance Between Wall Thickness Specifications

February 19, 2015 8:30 am | by Rick Shorey, Sr. Sales Engineer and Project Manager, Avalon Laboratories | Comments

Microchips for delivering drugs with time released capabilities or neuroscience, neuromodulation and/or monitoring devices material selection is key for both the implantable and delivery device. Depending upon duration and type of application...

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The Fragrant Stench of Discovery

February 18, 2015 3:03 pm | by Sam Brusco, Associate Editor, @SamISureAm | Comments

We’ve all been there – you lift your arm to wave hello to a friend or hail a cab, and an unpleasant odor causes you to cringe and hold your nose. Wondering where this foul scent could have possibly originated from, you look around for the source...

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