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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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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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