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The Lead

IBM's Watson Partners with CVS to Tackle Diabetes...and Much More

August 3, 2015 | by Sam Brusco, Associate Editor, @SamISureAm | Comments

Watson is extending its feelers (wires?) straight to the consumers, thanks to a partnership with CVS. Because of this partnership, Watson will now be able to predict people (i.e., CVS customers) who may be at risk for diabetes and other chronic diseases...


The Times They Are a Changin’ – And So Is FDA

August 3, 2015 2:50 pm | by Luciana Borio, M.D. | Comments

As our report FDA Science Moving Forward illustrates, FDA regulatory science programs have made dramatic advances in the last eight years. These advances are critical because, as I’m always reminded, regulatory science underpins virtually...

Cardiac CT Emerging as Mainstream Diagnostic and Screening Tool

August 3, 2015 10:43 am | by Randy Roundtree, VP Alliances, Healthcare Solutions, Calgary Scientific | Comments

Imaging is rapidly becoming a standard element in the screening and diagnosis of heart patients. Anyone heading to the ER with chest pains today may find themselves being sent for non-invasive imaging for diagnostic purposes instead of to a...


Are We in the Golden Age of Medical Devices?

July 29, 2015 8:30 am | by Jon Speer, Co-Founder & VP of QA/RA, | Comments

Right now, the medical device industry is in a “golden age.” Yes, it’s true that the high water mark for investment funding for this industry was in 2007. 2014 was the best year for med device investment funding since 2007. Despite an improved...


Improving Access to Medical Devices: FDA Uses Existing Clinical Data to Reduce Premarket Data Needs

July 28, 2015 8:30 am | by Ben Fisher, Ph.D. | Comments

At the FDA, we recognize the value of encouraging medical device innovation. We recently have acted to reduce the time and cost of clinical trials while maintaining patient protections. By doing so, FDA is helping to ensure that manufacturers will be

Don’t Let Product Development Go Off Course

July 27, 2015 8:30 am | by Tim Pelura, PhD, CEO; David Craig, Director of Operations and Interventional Services; Surpass Inc. | Comments

It is no secret that bringing medical innovation to market is a costly endeavor. By product launch, tens, or even hundreds, of millions of dollars and thousands of hours of engineering and testing have been expended. According to a 2010...


6 Ways to Find Innovation Inspiration

July 23, 2015 4:04 pm | by Julie Wheelan, Vice President, Marketing & Strategy, Edison Nation Medical | Comments

Feeling inspired is often characterized as an “aha!” moment, but that isn’t the reality for most. Coming up with a great idea doesn’t require a particular kind of genius — inspiration can strike spontaneously with the right trigger. If you think...


Might Micropumps Eliminate Sleep Apnea Masks?

July 23, 2015 12:10 pm | by Sean Fenske, Editor-in-Chief, @SeanFenske | Comments

Airing is being developed as a standalone (untethered) device that would “plug” into the person’s nostrils and pump the necessary air needed to eliminate the sleep apnea condition. This device is seeking investment through a crowdfunding...


Process Development Meets Virtual Reality

July 23, 2015 10:56 am | by Josh Simon, Adjunct Professor, New Jersey Institute of Technology | Comments

Developing video games requires a lot of skill which must be developed over time, but until recently it did not really occur to me how integrally the skills for game development and biomedical engineering could be connected. The connection is obvious...


MedTech Memoirs: 3 Disastrous Equipment Failures

July 22, 2015 2:03 pm | by Sam Brusco, Associate Editor, @SamISureAm | Comments

Most of the time, medical equipment functions exactly as intended. But sometimes even the most well-intentioned medical devices unexpectedly malfunction or cause unforeseen complications. With most consumer devices, a malfunction only...


Infertility Diagnosis Comes to Your iPad

July 22, 2015 12:04 pm | by Sean Fenske, Editor-in-Chief, @SeanFenske | Comments

Aidmics has developed a do-it-yourself home fertility test system that enables men to get an analysis of their sperm. Called the iSperm, the solution couples with an iPad mini via an optimized optical lens and diagnostic testing supplies...


IEC 60601-1 3rd Edition Risk Management Requirements and Product Design

July 22, 2015 10:46 am | by Michael Brousseau, Safety Engineer and Operations Manager, Intertek | Comments

The third edition of IEC 60601-1 has been on the books for nearly a decade, and an amendment has been out for three years. Yet the standard still challenges many in the medical device industry, particularly when it comes to risk assessment...


Curing Cancer Through Open Source Solutions

July 21, 2015 10:57 am | by Sean Fenske, Editor-in-Chief, @SeanFenske | Comments

In a connected world, hope, inspiration, and support can be just a few clicks away. The internet brings with it a wealth of information and support communities established specifically for the purpose of coming together to discuss “best...


Does Your Medical Innovation Have Legs in the New Healthcare Reality?

July 21, 2015 10:47 am | by Tim Pelura, PhD, CEO, Surpass Inc. | Surpass, Inc. | Comments

In the present era of affordable and accountable healthcare, how that care is delivered and managed has come under tremendous pressure – and cost containment is the order of the day. Likewise, the role of technology in the care continuum has...


Coming Soon: A Take-Home Herpes Test

July 20, 2015 4:01 pm | by Sam Brusco, Associate Editor, @SamISureAm | Comments

The FDA has recently approved a take-home HSV-1 test provided by Theranos, a company that provides diagnostic testing for hundreds of diseases with only a few drops of blood. Testers can now use Theranos’ finger-stick technology to test outside of the lab...


A Way Forward: Enabling Effective Clinical Decision-Making Through Simulation

July 20, 2015 10:31 am | by James B. McGee, MD Scientific Advisory Board Chairman and Co-Founder, DecisionSim Inc. | Comments

Much attention is being paid to the skill of “decision-making” in healthcare. This trend is driven by a number of factors including cost, patient safety, and an increasingly complex healthcare environment. Not only are there more diagnostic and...



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