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Six Steps That Optimize Your Medical Device for Manufacture

June 30, 2014 2:55 pm | by Mark Drlik, Mechanical Engineer and Project Manager, StarFish Medical | Comments

Many medical device manufacturing pitfalls come with the territory. Physical architecture, vendor selection, and even basic details like specifying the labels and fasteners on a part can raise costs or lower reliability. Follow the six steps...

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Trends and Developments in the European Companion Diagnostics Market

June 27, 2014 4:04 pm | by Richard Park, Contributing Editor | Comments

Frost & Sullivan recently released a report entitled, “Western European Companion Diagnostics Market.” This study provides a global outlook of the companion diagnostics market, specifically focusing on Western Europe. The report discusses...

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Filling Information Gaps for Women in Medical Device Clinical Trials

June 27, 2014 1:58 pm | by David Strauss, M.D., Ph.D., Medical Officer, Center for Devices and Radiological Health, FDA | Comments

At FDA’s Center for Devices and Radiological Health (CDRH), results from clinical trials often serve as the foundation for our decisions to approve the most important medical devices — devices, such as implantable heart devices, that carry...

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What the Medical Industry Can Learn from the Aerospace Industry

June 26, 2014 12:08 pm | by Bob Hill, President, Solar Atmospheres | Comments

Heat treatment standards are stricter in the aerospace industry than in the medical industry where lives are on the line. This doesn’t make sense and something is being done about it. Recently, I was asked to give a vacuum heat treating...

The War on Error

June 25, 2014 11:09 am | by Craig Jones, VP Global Supports Services, PRISYM ID | Comments

Product recalls in the medical devices industry are increasing – bringing a trail of destruction to companies’ operational efficiencies and profitability. Labeling error remains a common cause of recall – but it’s one that can easily be...

FDA Encourages Medical Device Data System Innovation

June 24, 2014 2:16 pm | by Bakul Patel, Senior Policy Advisor in Center for Devices and Radiological Health, FDA | Comments

Thanks to advances in digital health, doctors and their patients are more frequently using computer systems to collect medical data that can provide useful information on a patient’s health. Some of these systems, referred to as “medical...

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FDA Leverages Big Data via Cloud Computing

June 23, 2014 3:58 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

Last year, I worked with a group of colleagues throughout the Food and Drug Administration (FDA) on a project that is critical for the agency’s future: the modernization of our information technology platforms to prepare for the influx of...

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Breaking Down the Regulation of LDTs: FDA Authority

June 23, 2014 10:33 am | by Richard Park, Contributing Editor | Comments

During the past couple of 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...

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FDA Issues Draft Guidances for Industry on Social Media and Internet Communications About Medical Products

June 18, 2014 2:27 pm | by Thomas Abrams, Director – Office of Prescription Drug Promotion, CDER, FDA | Comments

Ongoing changes in technology transform medical products – and the ways that both patients and health care providers learn about those products. In today’s world, in addition to traditional sources of medical product information, patients...

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Life-Saving, Smart Regulation on Behalf of Patients with Aortic Stenosis

June 17, 2014 9:50 am | by Jeffrey Shuren, M.D., Director – Center for Devices and Radiological Health, FDA | Comments

At FDA’s medical devices center, we have a vision — it’s what we strive for each day in our review and assessment of new medical technology. And patients are at the very core of that vision: “Patients in the U.S. have access to high-quality...

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Unleashing Clinical Measurements

June 16, 2014 2:38 pm | by Angelo Corsaro, Ph.D., Chief Technology Officer, PrismTech | Comments

Medical devices are an essential element of modern medicine as they provide accurate clinical measurements such as oxygen saturation, blood pressure and temperature, x-ray and ultrasound imaging, as well as automatically administer intravenous...

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CDRH on Track to Improve Device Submission Review Process

June 13, 2014 2:00 pm | by Jeffrey Shuren, M.D., Director – Center for Devices and Radiological Health, FDA | Comments

FDA’s Center for Devices and Radiological Health (CDRH) is committed to speeding innovative new medical devices to market and to improving the efficiency of our device submission review process. That’s critical for patients getting access...

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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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