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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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MedTech and the Wireless Power Challenge

May 19, 2014 2:50 pm | by Dianne Kibbey, Global Head of Community, element14 | Comments

One sector that stands to gain a great deal from wirelessly powered devices is the medical industry. As we enter the age of self-administrable treatments, wearable technology and advanced surgical robotics, the sophisticated use of wireless...

Assessing FDA’s Crackdown of 23andMe

May 19, 2014 9:14 am | by Richard Park, Contributing Editor | Comments

Last November, FDA ordered 23andMe (Mountain View, CA) to discontinue offering its direct-to-consumer DNA testing service, which provided individuals with assessments of their genetic risk for nearly 200 diseases. Many had praised 23andMe’s...

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Medical Device Molding Insights

May 16, 2014 2:40 pm | by Jeff Randall, VP – Engineering, MRPC | MRPC | Comments

Following is a Q&A with Jeff Randall, Vice President of Engineering at MRPC. Randall offers a number of insights on molding for the medical device space. He discusses topics such as micro molding, materials, consumer medtech, UDI, and...

Build Your Avatar by Jogging

May 14, 2014 4:08 pm | by Jason Orszt, Editorial Intern | Comments

It all begins with what you know. When the Tamagatchi had rolled in, it was all the rage at elementary school. Everyone had some tiny animal; I had R2D2. You fed your pet or it died. Clean up after it or the pile grew higher. Run out...  

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Building Expertise and Crossing Boundaries to Improve Oversight

May 13, 2014 2:59 pm | by Howard Sklamberg, J.D., Deputy Commissioner for Global Regulatory Operations and Policy, FDA | Comments

To keep the food supply safe, have safe, effective, and high quality medical products, and decrease the harms of tobacco product use, we have to work with the rest of the world. As FDA’s Deputy Commissioner for Global Regulatory Operations...

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Five Hard-Learned Lessons from a Medical Device Start-Up

May 12, 2014 1:37 pm | by Emily Cross, Ph.D., Director of Media and Communication, TecMed Inc. | Comments

Just the idea of starting something from scratch can be overwhelming.  Ask the average shopper at your local grocer how they prepare a simple meal at home and you’ll find the majority who cook use prepared ingredients, making the whole...

Trends in the U.S. IVD Market: Diseases and Testing Venues

May 12, 2014 9:06 am | by Richard Park, Contributing Editor | Comments

My blog last week looked at a report released by Kalorama Information entitled, “The United States Market For In Vitro Diagnostic Tests.” This report examines the current state of the U.S. IVD market, analyzes the various emerging trends...

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