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Drive to Repeal Medical Device Tax No Slam Dunk in Congress

February 2, 2015 12:51 pm | by Alan Fram, Associated Press | News | Comments

It flew through the Republican-run House in 2012, and a year later 79 of the Democratic-led Senate's 100 members embraced it. With Republicans now controlling both chambers of Congress, the chances for repealing the 2.3 percent tax on medical devices...

State Declares Electronic Cigarettes a Health Threat

January 30, 2015 10:51 am | by Fenit Nirappil, Associated Press | News | Comments

California health officials Wednesday declared electronic cigarettes a health threat that should be strictly regulated like tobacco products, joining other states and health advocates across the U.S. in seeking tighter controls as "vaping" grows in...

Mayo Clinic Expert Explains Telemedicine Benefits and Policy Changes

January 30, 2015 10:21 am | by Mayo Clinic | News | Comments

If you haven’t already experienced telemedicine, you may soon have the option. Technology is helping people connect with their physicians in new ways and from a distance, and interest is growing in updating state and federal policies to help...

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Medical Device Tax Led To Thousands Of Job Cuts

January 30, 2015 10:11 am | by Andy Szal, Real Time Digital Reporter, Manufacturing.net | News | Comments

A recent survey conducted by a medical technology trade group blames a tax on medical devices for about 18,500 industry job cuts in the last two years. The Advanced Medical Technology Association said the tax -- which was enacted as part of...

Is Your New Mobile Health App Secure in 2015?

January 30, 2015 8:30 am | by David Surber, VP of Medical Products, TÜV Rheinland | Blogs | Comments

It is estimated that 500 million smartphone users worldwide will use healthcare applications in 2015 – from using the phone to detect glaucoma in the eye to taking cardiac measurements. The users include healthcare professionals, consumers, and...

Fitness Trackers, Other Wearables Not Subject to Regulatory Scrutiny

January 29, 2015 8:38 am | by AAMI | News | Comments

The U.S. Food and Drug Administration’s (FDA) device division has unveiled new draft guidance in which it reiterates that it does not intend to regulate low-risk general wellness products. The agency also tells manufacturers how they can...

Speeding Up Diagnosis and Embracing Telehealth in 2015

January 29, 2015 8:30 am | by Dan Piekarz, Vice President of Business Development, Life Sciences, DataArt. | Blogs | Comments

Technology implemented well is greatly increasing our ability to understand the human body and how to care for it. In 2015, next generation genetic sequencing techniques will be revolutionizing diagnosis of infectious disease, but the FDA's...

A CDRH Priority: Clinical Trials in the U.S.

January 28, 2015 3:47 pm | by Owen Faris, Ph.D., and Jeffrey Shuren, M.D., J.D. | Blogs | Comments

At the Center for Devices and Radiological Health (CDRH), clinical trials are the foundation for our decisions to approve the most important medical devices—products that have the potential to save or sustain life, but that also present the greatest...

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Improving Reliability of Automated External Defibrillators

January 28, 2015 11:05 am | by U.S. Food and Drug Administration | News | Comments

The U.S. Food and Drug Administration announced today that it will strengthen its review of automated external defibrillators (AEDs) to help improve the quality and reliability of these devices. The FDA issued a final order that will require...

2015 Will Require Implementation of Thorough Security Programs

January 28, 2015 8:30 am | by Michael McNeil, Product Security & Services Officer, Philips Healthcare | Blogs | Comments

In April of 2014, Wired Magazine made the rattling proclamation that “it’s insanely easy to hack hospital equipment,” citing cybersecurity researcher Scott Erven’s two years of medical device vulnerability investigations and the many ways in...

How to Trick a Fitness Tracker

January 27, 2015 9:01 am | by Megan Crouse, Real Time Digital Reporter, Design Group | News | Comments

Basketball drills, passing fads, and how to trick a fitness tracker – fitness trackers are good at tracking steps on a walk, but not so much at tracking how many calories someone burns, said a study begun by the American Council on Exercise...

Testing for Ion Release from Surgical Implants

January 23, 2015 3:22 pm | by ASTM International | News | Comments

Although regulatory bodies, including the U.S. Food and Drug Administration, frequently request information from manufacturers on the potential for ion release from surgical implants containing metal, there has not been a standard method for...

The Future Is Here…Finally

January 23, 2015 1:50 pm | by Sean Fenske, Editor-in-Chief | Blogs | Comments

As far as actually looking ahead when it comes to 3D printing, I foresee the need for a fundamental shift in the way medical device makers offer some types of medical technologies. Rather than buying a finished product from a manufacturer or distributor...

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Australia, Brazil, Canada, Japan, and the US: Safeguarding Medical Devices

January 23, 2015 10:20 am | by Kim Trautman, M.S., Associate Director of International Affairs, Center for Devices and Radiological Health | Blogs | Comments

The FDA and its regulatory counterparts abroad have the weighty responsibility of ensuring the safety of the thousands of regulated medical devices imported in their countries each year. To make this task more manageable, FDA and regulatory...

Cyber Security Challenges for Personal Medical Devices

January 22, 2015 4:22 pm | by Greg Shannon, PhD, Chair, IEEE Cybersecurity Initiative, and Chief Scientist, CERT Division, Carnegie Mellon University Software Engineering Institute | Blogs | Comments

Personal medical devices (PMDs) governed by software, identified by an Internet Protocol (IP) address and connected to the Internet of Things (IoT) present a myriad of challenges. Certainly cyber security of the device and its personally...

Sparton Acquires Real-Time Enterprises, Inc.

January 22, 2015 4:03 pm | by Sparton | News | Comments

Sparton Corporation announced that its wholly owned subsidiary, Sparton Design Services, LLC completed the acquisition of Real-Time Enterprises, Inc., a $4 million revenue business, on January 20, 2015 in an all-cash transaction. RTEmd will...

Designing a Smarter Trial, Earlier

January 21, 2015 1:58 pm | by Vicki Anastasi, VP and Global Head of Medical Device and Diagnostics Research, ICON | Blogs | Comments

Increased regulatory and reimbursement burden has made development timelines longer than ever. As regulators and payers demand more evidence to demonstrate safety, efficacy, and value, manufacturers must design smarter trials that collect...

Zapping Away the Pounds, but What Zaps Away the Habit?

January 16, 2015 3:06 pm | by Sean Fenske, Editor-in-Chief | Blogs | Comments

There is no doubt that losing excess weight can help to eliminate an array of health concerns or reduce the risk of their occurrence. Unfortunately, the process of actually shaving off those pounds can pose a significant challenge. So it will come as great...

Connectivity and Internet of Things Will Transform Availability of Healthcare

January 16, 2015 9:55 am | by Sean Fenske, Editor-in-Chief | Blogs | Comments

Connectivity, which is often referred to as the “Internet of Things” and associated wireless capabilities, are providing a new framework for improving virtually every aspect of healthcare. This includes shifting from reactive to preventative healthcare...

Congress Takes Aim at the Device Tax

January 15, 2015 11:00 am | by AAMI | News | Comments

The long-running fight to repeal the 2.3% medical device excise tax has taken center stage with a new Republican-led Congress in session and the introduction of bills in both chambers to kill it.The tax, designed to help fund President Obama’s...

The Proposal: Making a Commitment to Labeling

January 15, 2015 9:40 am | by Darren Altkinson, PRISYM ID | Articles | Comments

The recent introduction of UDI requirements has persuaded many medical device companies to review their labeling capabilities. This, alongside other regulatory, technological and market drivers, has led to a growing number of companies issuing...

Securing the Medical Supply Chain: How to Prevent Counterfeit Plastic Parts and Products

January 13, 2015 9:00 am | by Plastics Color Corp. | Articles | Comments

While counterfeiting statistics are difficult to obtain because it is a “clandestine” industry, one thing everyone can agree on is that counterfeiting is big business. As the world has grown smaller and the supply chains for major corporations...

Top 10 Healthcare Technology Issues for 2015

January 12, 2015 12:01 pm | by ECRI Institute | News | Comments

The latest healthcare technologies and care process innovations are pounding on hospital doors and looking through windows—and they want in. Will they actually improve patient care, or inflate hospital budgets for infrastructure, capital...

Agency Aims to Guard Infusion Pumps against Cyberthreats

January 8, 2015 11:28 am | by AAMI | News | Comments

Citing new risks and vulnerabilities involving medical devices, a center within the National Institute of Standards and Technology (NIST) is seeking public feedback on a draft document that examines how to address cybersecurity challenges related...

Industry Associations Support Efforts to Repeal Device Tax

January 8, 2015 9:12 am | by Powell Tate | News | Comments

The Medical Imaging & Technology Alliance (MITA), Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA) today applauded the introduction of bipartisan legislation to repeal the 2.3 percent...

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