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Breaking Down the Regulation of LDTs: FDA Jurisdiction

June 13, 2014 1:54 pm | by Richard Park, Contributing Editor | Comments

A couple of weeks ago, I reported on a letter that Bradley M. Thompson, JD, and James A. Boiani, JD, attorneys at Epstein Becker Green, recently sent to FDA Commissioner Margaret Hamburg. The attorneys sent this letter on behalf of the... 

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Haptic Device Simulates the Feel of Breasts

June 11, 2014 3:56 pm | by Jason Lomberg, Technical Editor, ECN | Comments

Check those smirks. This doesn’t concern a certain less-than-reputable industry (banking $100 billion+ annually) or Japan’s general proclivity for weirdness. Actually, the ability to simulate the tactile sensation of soft breast tissue could have important medical applications ...

Why Bother? Is the Fight Really Worth It?

June 9, 2014 10:17 am | by Emily L. Cross, Ph.D., Director of Media and Communication, TecMed Inc. | Comments

In some eyes, TecMed, Inc. might be considered the world’s longest standing medical ‘start-up.’ Even CEO Alan Leszinske claims that the name ‘start-up’ might be a bit erroneous since the company has been in full swing for nearly 2 decades...

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Cloud Technology in e-Health

June 6, 2014 3:04 pm | by Mary Lynne Nielsen, Technology Initiatives Director, IEEE Standards Association | Comments

Innovation across an array of technology areas—personal health device communications, cloud computing, the smart grid, cyber-security and “Big Data” analytics, among them—have helped the global healthcare community to envision a whole new...

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Trends in the U.S. IVD Market: Market Segments and Conclusions

June 6, 2014 1:55 pm | by Richard Park, Contributing Editor | Comments

According to the report, professional point-of-care diagnostics is the largest IVD segment in the U.S. and generates $3.6 billion in annual revenues. The volume of this segment reflects the high penetration of point-of-care testing products...

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Medical Technology Highlights of 2014 Symposia on VLSI Technology & Circuits

June 5, 2014 4:01 pm | by Jeffrey Gealow, Circuits Program Chair, 2014 Symposia on VLSI Technology & Circuits | Comments

The integration of more advanced electronics technology into medical devices for patient monitoring, diagnosis and treatment continues at an ever-increasing rate, with new developments being announced daily. Among these significant technology...

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New Challenges/Opportunities for Medical Device Manufacturers Forged by the ACA

June 3, 2014 4:04 pm | by Claudio Bellini, COO, COSMED USA | Comments

Amid all the back-and-forth political discussion and controversy surrounding the Affordable Care Act, one fact is clear: more people will have access to traditional healthcare services than ever before. And with that reality, it has become...

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OpenFDA: Innovative Initiative Opens Door to Wealth of FDA’s Publicly Available Data

June 2, 2014 3:48 pm | by Taha A. Kass-Hout, M.D., M.S., Chief Health Informatics Officer and Director – Office of Informatics and Technology Innovation, FDA | Comments

Today, I am pleased to announce the launch of openFDA, a new initiative from our Office of Informatics and Technology Innovation (OITI). OpenFDA is specifically designed to make it easier for web developers, researchers, and the public to...

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Breaking Down the Regulation of LDTs

June 2, 2014 11:34 am | by Richard Park, Contributing Editor | Comments

I received a copy of a letter that Bradley M. Thompson, JD, and James A. Boiani, JD, attorneys at Epstein Becker Green, recently sent to FDA Commissioner Margaret Hamburg. The attorneys sent this letter on behalf of the Combination Products...

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Report on Medical Device Market Outlines Challenges, Opportunities for Cost Containment

May 30, 2014 3:44 pm | by Rich Gedney, CEO, ADMET | Admet, Inc. | Comments

The medical device market has experienced tremendous growth, reaching more than $330 billion worldwide. While the industry remains healthy, several challenges face those who design and manufacture medical devices. ADMET serves this market...

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When Developing Medical Devices, Don’t Forget the Economic Advantages Compared to Expensive Drug Alternatives

May 27, 2014 3:03 pm | by Charlie Whelan, Senior Analyst, Healthcare & Life Sciences, North America, Frost & Sullivan | Comments

Recent news stories about the high cost of two new drugs targeting Hepatitis C, Gilead’s Sovaldi (sofosbuvir) and Janssen’s Olysio (simeprevir), have raised the question of whether the U.S. healthcare system is on an irreversible track toward...

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Trends in the U.S. IVD Market: Medicare Reimbursement and the Affordable Care Act

May 23, 2014 2:10 pm | by Richard Park, Contributing Editor | Comments

According to the report, the continuing economic recovery and the expansion of the health insured population nationwide through the Affordable Care Act (ACA) are expected to increase health expenditures beyond the U.S. economy’s growth rate...

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Taking Healthcare Home with Phones and Wearables

May 22, 2014 8:30 am | by Tom O’Dwyer, Director of Healthcare Technology, Analog Devices | Analog Devices, Inc. | Comments

Traditionally, people think of healthcare as taking place at the hospital or in a clinical setting where a physician is measuring the body — and vital signs in particular. But healthcare in the last couple of years has evolved out of the...

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Desires Lie in More Minimally Invasive and Accommodating Medical Devices

May 21, 2014 4:27 pm | by Jinny Lee, Vice President of Strategic Marketing, Advanced Technology, Edwards Lifesciences | Comments

What is remarkable about medical technology today – that wasn’t the case 10 or 15 years ago – is that we are performing surgical procedures with minimal incisions or with catheter-based approaches, which promise a number of potential benefits...

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3D Printing a Healthcare Revolution

May 20, 2014 2:22 pm | by Sean Fenske, Editor-in-Chief | Comments

3D printing is one of those truly disruptive technologies that comes along very rarely. It is remarkable how many different industry sectors it can touch and impact significantly. Healthcare is just one area where it is making a difference...

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