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Mobile Vital Signs Monitoring Devices Will Revolutionize Healthcare

December 12, 2014 8:00 am | by Sean Fenske, Editor-in-Chief | Analog Devices, Inc. | Comments

Over the next five years, we are likely to see vital signs monitoring as a universal facet of everyday life. The sensing will be discreet, convenient, and painless. Expert systems will sit quietly in the background and occasionally rear their head to warn...

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Using Smartphone Cameras as Test Strip Reading Devices

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

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Might Portable Clean Air Hold the Key for Better Health?

December 11, 2014 2:39 pm | by Sean Fenske, Editor-in-Chief | @SeanFenske | Comments

There’s little argument when it comes to the value of clean air. Air pollution – bad! Clean, fresh air – good! However, is creating an environment where someone is exposed to clean air exclusively a good idea? I happened upon a device that is being...

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Collaborating With Clinicians to Set Standards

December 11, 2014 7:30 am | by Tom O’Dwyer, Director of Healthcare Technology, Analog Devices | Analog Devices, Inc. | Comments

Home healthcare can really be divided into two sub-sections, clinical-grade and non-clinical grade. Clinical grade is currently limited largely to glucose testing and blood pressure cuffs. Non-clinical grade refers to areas such as...

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Implementation of the UDI System Is Critical to Public Health

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

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Easing the Burden on Healthcare Professionals

December 10, 2014 7:30 am | by Jan Wittenber, Member of IEEE and Fellow at the Center for Medical Interoperability | Comments

The following from the Background section of the ISO/IEEE 11073 Personal Health Data (PHD) Standards addresses this topic appropriately: “Demographics changes (the rapidly aging population in many industrialized countries) and an increase...

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Home (Healthcare) Is Where the Need Is

December 9, 2014 7:30 am | by Carlos Castillo, Biomedical Engineer & Research Biomedical Engineering Advisor, Loma Linda University Zhang Neuroscience Laboratory | Comments

Short answer, where the need is! Perhaps numbers will make this more clear. Sen. Rob Portman (R-Ohio) gives us the first part of this equation “Each day, 10,000 baby boomers retire and begin receiving Medicare and Social Security benefits”... 

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IVD Companies Join Ebola Fight

December 8, 2014 9:58 am | by Richard Park, Contributing Editor | Comments

While the initial hysteria and fear of an Ebola pandemic has quieted down, the fight against this disease is far from over. National Public Radio reported that there were 537 new Ebola infections in Sierra Leone in one week, which is the largest weekly...

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Bionic Bra Proves Necessity Is Apparently Not the Mother of Invention

December 8, 2014 9:34 am | by Melissa Barnes, Associate Editor | Comments

The recent story about a “Bionic Bra” from the University of Wollongong had me wondering...why?! Of all the medical devices we have a dire need for, a sensor-equipped, “smart yarn”-infused, automatic-tightening bra certainly isn’t one of them. The...

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Exploit Opportunities Offered by UDI Initiative

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

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A Harmonic Convergence of MedTech

December 5, 2014 2:08 pm | by Sean Fenske, Editor-in-Chief | Comments

Honestly, if you attend Medica and don’t find yourself exhilarated by all the creativity and innovation that’s happening in the medtech space, you’re in the wrong job. The event is not just an educational or networking opportunity, but rather an event that truly celebrates medical technology...

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Friday 5: Connecting Healthcare with TE Connectivity's Thomas Medina

December 5, 2014 9:42 am | by Sean Fenske, Editor-in-Chief | Comments

I foresee a continuous transition from body-worn to body-integrated devices designed to deliver very specific, customized care. Device function will be monitored and controlled remotely, determined via gene-based diagnosis and therapies; and will be...

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Trust, But Verify In Order to Comply with UDI

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

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Develop an Internal Team for UDI

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

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Roll-Out UDI to the Device Manufacturer and Supply-Chain Partners

December 3, 2014 7:30 am | by Matt Kelly, Key Account Manager, Medical, Watlow | Comments

The Food and Drug Administration (FDA) has released a final rule requiring that most medical devices distributed in the United States carry a unique device identifier, or UDI. A UDI system has the potential to improve the quality of...

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