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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...

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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...

The ACA Has Clogged the Pipeline of MedTech Innovation

December 31, 2014 9:30 am | by Emily L. Cross, Ph.D., Director of Media and Communication, TecMed Inc. | 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...

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

December 30, 2014 9:55 am | by Mike Rozembajgier, Vice President, Stericycle | 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 | by Bill Ash, Strategic Technology Program Director, and Kathryn Bennett, Senior Program Manager, IEEE Standards Association | 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 | by Bill Betten, VP of Business Solutions, Logic PD | 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 | by Sean Fenske, Editor-in-Chief | 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 | by Mika Javanainen, Senior Director of Product Management, M-Files Corporation | 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...

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UDI Update from the FDA

December 22, 2014 9:17 am | by FDA | 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 | by Richard Park, Contributing Editor | 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 | by TEDMED | 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 ...

Using Smartphone Cameras as Test Strip Reading Devices

December 12, 2014 7:30 am | by Thomas M. Tsakeris, President, Devices and Diagnostics Consulting Group | Blogs | Comments

In my experience as a regulatory consultant mainly in the IVD area, I have observed over the last year or so an increasing interest in linking traditional IVD home-use test strips such as urinalysis (protein, pH, glucose keytones, nitrite, etc...

Implementation of the UDI System Is Critical to Public Health

December 10, 2014 10:33 am | by Jeffrey Shuren, M.D., Director, CDRH | Blogs | Comments

As the FDA works with manufacturers to launch a new system of identifying medical devices using standard bar codes and numbers, we look forward to the day when the system, called the Unique Device Identifier (UDI) system, will be fully set up — with...

Stryker Will Pay About $80M to End Investigation

December 9, 2014 11:46 am | by The Associated Press | News | Comments

The medical device maker Stryker will pay about $80 million to end a federal investigation into its acquisition of a company that the U.S. said was marketing a product that hadn't been approved by regulators. The company said that the U.S...

Addressing the Top Five Software Validation Questions

December 9, 2014 9:48 am | by Penny Goss, Consultant, Penny Goss Technical Solutions | Articles | Comments

The FDA (Food and Drug Administration) and IEC (International Electrotechnical Commission) requirements for validation of manufacturing and quality system software can conjure up a lot of questions. Understanding the actual guidelines and best...

Medical Device Makers: You’re Responsible for Device Cybersecurity

December 8, 2014 11:06 am | by AAMI | News | Comments

Who is responsible for the cybersecurity of medical devices? The makers of those devices. That anyway is the position of the American Hospital Association (AHA), which made its point in comments submitted to the U.S. Food and Drug Administration...

Exploit Opportunities Offered by UDI Initiative

December 8, 2014 7:30 am | by Dave Taylor, Vice President, Global Products, PRISYM ID | Blogs | Comments

Sep. 24 saw the first UDI compliance deadline which means that organizations should now be focusing on the implementation phase, following a thorough preparation phase reviewing all current processes and systems in place. The implementation...

Trust, But Verify In Order to Comply with UDI

December 5, 2014 7:30 am | by Steve Cochran, Chief Technology Officer, GHX | Blogs | Comments

“Trust, but verify” is my advice to manufacturers seeking to comply with the UDI rule. As a third party submitter that has successfully loaded data into the Global UDI Database (GUDID), I can confidently tell manufacturers, "trust that it...

Develop an Internal Team for UDI

December 4, 2014 7:30 am | by Deborah Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions | Blogs | Comments

Working with industry, we still see a need for more internal conversations among various stakeholders within organizations for an effective rollout of UDI. This is because the regulation has “amended” many existing regulations that will impact...

Green Light from FDA for CT Lung-Imaging Software

December 3, 2014 11:08 am | by University of Michigan Health System | News | Comments

A technology that started in a University of Michigan Medical School lab may soon help lung disease patients around the world breathe a little easier, by helping their doctors make a clearer diagnosis and more individualized treatment plan. Imbio...

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