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Fitness Trackers, Other Wearables Not Subject to Regulatory Scrutiny

January 29, 2015 8:38 am | 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The U.S. Food and Drug Administration’s (FDA) device division has unveiled new draft guidance in which it reiterates that it does not intend to regulate low-risk general wellness products.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 | Blogs | Comments

Technology implemented well is greatly increasing our ability to understand the human body...

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

January 28, 2015 3:47 pm | Blogs | Comments

At the Center for Devices and Radiological Health (CDRH), clinical trials are the...

Improving Reliability of Automated External Defibrillators

January 28, 2015 11:05 am | News | Comments

The U.S. Food and Drug Administration announced today that it will strengthen its review of...

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2015 Will Require Implementation of Thorough Security Programs

January 28, 2015 8:30 am | 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 | 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 | 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...

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The Future Is Here…Finally

January 23, 2015 1:50 pm | 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...

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

January 23, 2015 10:20 am | 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 | 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 | 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 | 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...

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

January 16, 2015 3:06 pm | 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 | 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 | 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 | 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 | 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...

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Top 10 Healthcare Technology Issues for 2015

January 12, 2015 12:01 pm | 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 | 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 | 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...

The ACA Has Clogged the Pipeline of MedTech Innovation

December 31, 2014 9:30 am | Blogs | Comments

The 2010 media was saturated in the triumphant, albeit hotly debated, arrival of change in many sectors of life, but spun tightly on the U.S. healthcare system. The year can be defined with tedious chatter, increased expectations, and a new sensation...

Examining Why It’s Not All Blue Skies for Medical Device Recalls

December 30, 2014 9:55 am | Blogs | Comments

According to the most recent Stericycle Recall Index, FDA Enforcement Reports documented 297 medical device recalls in Q3. This is a slight increase from the prior quarter, but overall the industry has not witnessed the dramatic fluctuation in recalls...

Expanding Wellness Monitoring and Care with e-Health

December 29, 2014 9:11 am | Blogs | Comments

In the next-generation e-health environment that is taking shape in markets worldwide, more varieties of more accurate patient data will be more efficiently exchanged and analyzed across a wider array of interoperable devices and systems for enhanced...

Healthcare in Real Time: The Speed of Disruption

December 24, 2014 8:54 am | Logic PD, Inc. | Blogs | Comments

I recently had the pleasure of leading a panel discussion on the title topic at LifeScience Alley’s health technology leadership conference in Minneapolis. The panel consisted of technologists involved in developing medical products who engaged in a discussion...

The MDT Top 10 from 2014

December 23, 2014 2:03 pm | Blogs | Comments

Another exiting year of medtech innovations has passed. In 2014, we really started to see the impact of mHealth on the industry, with more “outsiders” seeking to bundle health monitoring into smart phones and connected devices. Data security (and...

Hybrid Cloud – A Safe Play for Medical Device Manufacturers

December 23, 2014 8:02 am | Blogs | Comments

When every new technology innovation or computing model has to be evaluated within the constraints of complex and strict regulatory requirements, it is no surprise that medical device manufacturers have been skittish about moving to the cloud. Even as cloud...

UDI Update from the FDA

December 22, 2014 9:17 am | News | Comments

Having passed the first Unique Device Identification System compliance date of September 24, 2014 (for Class III devices and devices licensed under the Public Health Service Act), the FDA’s Center for Devices and Radiological Health (CDRH) would like...

Battle Lines Being Drawn Over LDT Regulation

December 15, 2014 9:54 am | Blogs | Comments

“The heart of Bradley Thompson’s argument rests on, ‘if a company is manufacturing an IVD test, the agency has full authority.’ Developing and performing most LDTs is not ‘manufacturing’ in a recognized sense of the word and never has been (although...

A Delicate Balance: How Can We Rightsize Treatment Costs?

December 12, 2014 10:43 am | Videos | Comments

It’s a familiar idea: the price of a product is whatever the market will bear - the highest price people are willing to pay becomes the price of the product. But applying that notion to healthcare demands that we address many questions ...

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