Pharmaceutical Innovations Inc.

In July 2016, Pharmaceutical Innovations Inc. of Newark, NJ, pleaded guilty to criminal charges around its distribution of ultrasound gel contaminated with bacteria, according to a U.S. Department of Justice press release

According to...

August 19th, 2016
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IT cybersecurity and medical product cybersecurity have different priorities. Here's how to ensure your IT team has the tools it needs.

Stephanie Domas

Manufacturers are at various levels of preparedness when it comes to cybersecurity for medical devices, but are sincerely trying to get up to speed. The latest thinking in this space—by regulators, manufacturers, and solution providers—revolves around the difference between IT cybersecurity on the corporate/enterprise level and product cybersecurity

While IT security is traditionally focused on compliance and securing enterprise systems such as laptops and servers, medical product cybersecurity is focused on risk management, hardware and software development.

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August 18th, 2016
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Users and clinicians want more than just a product from device companies. Here's what medtech companies need to know to get ahead as the industry partners with providers and moves toward offerings that support customers.

Marie Thibault

Medtronic is undergoing a transformation. So are GE Healthcare and Stryker.

But if you thought that the conversion from device maker to integrated care partner was simply a trend meant for the largest medtech companies—think again. The entire industry is shifting toward offering more services and training to help customers optimize medical care.

A recent report from PwC Health Research Institute, "...

August 17th, 2016
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Catheter-based delivery systems have helped push heart valve replacement technologies forward. What's next on the horizon?     

Jamie Hartford

Zeus is exploring tubing with a liquid crystal polymer monofilament braid (left) that could make braided catheters MRI-compatible. Shown on the right is tubing with a stainless-steel braid.     

Transcatheter heart valve therapies are among the hottest areas in medtech right now. Transcatheter aortic valve replacement (TAVR)—a...

August 17th, 2016
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An expert shares four things he's learned about the 510(k) submission process that you can use to your advantage.

Jon Speer

As you are probably aware, a 510(k) submission is required in order to get FDA market clearance for nearly all Class II devices.

With each 510(k) submission I am part of, there are definitely things to learn and to apply to future medical device product development projects and 510(k) submissions.

Here are four things I’ve learned about the FDA 510(k) submission process that you can use to your advantage to ensure a smooth process.

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August 17th, 2016
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Tips and tricks for medical device manufacturers to ensure they meet the upcoming UDI deadline.

Steve Cottrell and Madris Tomes

The American Hospital Association (AHA) saw the need for the medical device industry to have a single identification system for all medical devices. Even though previously it was possible to track and identify various medical devices, a global unified system was lacking.

In 2007 Unique Device Identification (UDI) was implemented by Congress in line with the FDA Amendments Act, which was then followed by the publication of the final rule in 2008. In order to be able to correctly identify medical devices through their distribution and use, the FDA used the final rule to implement different compliance dates for all new UDI...

August 17th, 2016
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A new medical computer tackles the ubiquitous challenges of power supply, mobility, and secure connectivity within hospitals and care facilities. 

Marie Thibault

The DT594 medical computer, part of the DT590 series, uses hot-swappable batteries that allow batteries to be changed while the computer keeps operating. 

WOWs, COWs, and COW Corrals—what? Those aren't ranching terms. These acronyms for Computers on Wheels (COWs) and Workstations on Wheels (WOWs) are familiar to many hospital clinicians, nurses, and adminstrators. Unfortunately, the problem of COW Corrals, when multiple computers are abandoned in an area of the facility because they...

August 16th, 2016
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Kinesio Tape

What it is: Kinesiology tape is an elestic tape that is usually applied by a therapist. It is long-wearing and is worn for perceived healing, pain relief, and support benefits.

Who uses it: U.S. beach volleyball Olympian Kerri Walsh Jennings, U.S. Olympian marathoner Meb Keflezighi, and NBA star/U.S. basketball Olympian James Harden are all brand ambassadors for KT Tape, a kinesiology tape brand.

The science: A 2014 meta-analysis found that kinesio...

August 15th, 2016
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Marc Pro

What it is: The Marc Pro is an FDA-cleared OTC device intended to help athlete recover and condition. The device is designed with two channels, each with two electrodes that can be placed over target muscles. 

According to the corporate website, the Marc Pro differs from other electrical muscle stimulators because it "employs a proprietary dynamic decaying waveform" to "comfortably contract muscles and then slowly release them over a period of time." The company also sells the Marc Pro Plus for temporary pain relief.

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August 15th, 2016
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As the Olympics have turned athletes from all over the world into household names, this attention has turned a spotlight on the health and sport technologies these athletes swear by. What is the science behind these technologies? 

Cupping went mainstream last week, as television viewers saw Olympic swimmers with the telltale suction marks on their backs and shoulders standing on the medal podium. Cupping is just one of the many technologies elite athletes have in their arsenal to keep them in tip-top shape.

Here are a number of technologies that Olympians use to help them perform at their best. What's the science behind each technology and what results have...

August 15th, 2016
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