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Breaking Down the Regulation of LDTs: Moving Forward

August 4, 2014 3:29 pm | by Richard Park, Contributing Editor | Comments

The letter stated that in order to move toward equal regulation, FDA should share its thinking on what it believes LDT regulation under FDCA should look like in practice, or how it plans to deregulate IVDs, by releasing its draft guidance...

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This first-aid kit is a must-have

July 31, 2014 11:11 am | by Kasey Panetta, Managing Editor, ECN | Comments

The Clever Medkit is a first-aid kit to end all first-aid kits. This over-the-top technologically advanced kit is technically designed for businesses, but I would consider this for a home purchase because I am a germaphobe and hypochondriac. (Yesterday, I used a Lysol wipe on my pens.) So, let's walk through the process of injuring yourself and using this bad boy.

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Eight Areas That Can Make or Break Your Medical Device Success

July 30, 2014 6:57 pm | by Vincent Crabtree, PhD, StarFish Medical | Comments

Identifying areas of greatest weakness is an important sanity check that will pay off while raising funds, clearing regulatory approval, and accessing the market for a new medical device. The eight areas described below can make or break your medical device success.

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The LDT Letter Battle

July 28, 2014 9:30 am | by Richard Park, Contributing Editor | Comments

Earlier this month, five democratic U.S. Senators sent a letter to the Office of Management and Budget (OMB) regarding the regulation of laboratory-developed tests (LDT). In this letter, Senators Edward J. Markey (D-MA), Richard Blumenthal...

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How to Sort Out Innovation, Value, and Value Chains for Medical Devices

July 23, 2014 2:09 pm | by Annelies Tjebbes, QA Specialist/Biomedical Engineer, StarFish Medical | Comments

A vital question to ponder before diving head first into medical device innovation is: For whom should we be creating value? Is it best to focus on value creation for patients? For doctors? For hospital purchasing departments? In the world of...

A Curriculum for Medical Device Progress

July 22, 2014 3:44 pm | by Francis Kalush, Ph.D., senior science advisor, Center for Devices and Radiological Health, FDA | Comments

Horace, the greatest Roman poet of antiquity, spoke of the need to “seek for truth in the groves of Academe” — and in the last four years, my colleagues in FDA’s Center for Devices and Radiological Health (CDRH) and I took his advice. In...

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Why Remote-Controlled Birth Control Will Be the Next Big Thing

July 22, 2014 3:31 pm | by Kasey Panetta, Managing Editor, ECN | Comments

In the midst of the Hobby Lobby court case decision and other conversations about birth control, there has been an announcement about an advancement in contraceptive technology. This is a pretty unique technology that would allow the woman...

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Breaking Down the Regulation of LDTs: Access to Innovative IVDs

July 21, 2014 9:10 am | by Richard Park, Contributing Editor | Comments

During the past few weeks, I’ve been reporting 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...

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U.S. Department of Veterans Affairs Leads the Way to Provide Better Care with Telehealth

July 18, 2014 2:20 pm | by Pierre Lemire, President and CTO, Calgary Scientific | Comments

Every month more than 250,000 Americans turn 65, according to a recent article and as the population gets older, the need to embrace cost-effective healthcare solutions continues to grow. One of those solutions is telehealth. A leader...

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OpenFDA Provides Ready Access to Recall Data

July 17, 2014 3:01 pm | by Taha A. Kass-Hout, M.D., M.S., Chief Health Informatics Officer and Director of Office of Informatics and Technology Innovation, FDA | Comments

Every year, hundreds of foods, drugs, and medical devices are recalled from the market by manufacturers. These products may be labeled incorrectly or might pose health or safety issues. Most recalls are voluntary; in some cases they may be...

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Not Quite Rock Stars, But Ready to Take Center Stage

July 16, 2014 11:42 am | by Emily Cross, Ph.D., Director of Media and Communication, TecMed Inc. | Comments

My earlier posts have focused on issues relevant to the business side of TecMed Inc. that we thought were relevant to any medical device technology start-up. Friends and peers have mentioned that the articles have been easily pertinent to...

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Developing New Tools to Support Regulatory Use of “Next Gen Sequencing” Data

July 15, 2014 3:00 pm | by Carolyn A. Wilson, Ph.D., Associate Director for Research Center for Biologics Evaluation and Research, FDA | Comments

When you’re thirsty, you don’t want to take a drink from a fire hose. And when scientists are looking for data they don’t want to be knocked over with a flood of information that overwhelms their ability to analyze and make sense of it. That’s...

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Why Contraception by Remote Control Is a Troubling Idea

July 14, 2014 10:41 am | by Chris Warner, Executive Editor, ECN | Comments

Forget about remembering to take a contraceptive pill. In just a few years, keeping track of your remote control may be as essential to family planning as it is to watching TV. MicroCHIPS, a small, Massachusetts company with backing from Bill Gates...

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Merck Committed to Companion Diagnostics

July 11, 2014 4:27 pm | by Richard Park, Contributing Editor | Comments

During the past month and a half, pharmaceutical giant Merck has been actively forming partnerships with IVD manufacturers to develop companion diagnostics for their drugs. The following is a rundown of these recent alliances. At the end of...

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FDASIA at Year Two

July 10, 2014 9:33 am | by Margaret A. Hamburg, M.D., Commissioner, FDA | Comments

Anniversaries are a time for stock-taking and today, on the second anniversary of the Food and Drug Administration Safety and Innovation Act or FDASIA, I’m pleased to report on the progress we’ve made implementing this multi-faceted law. To...

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