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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 | Blogs | 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...

Breaking Down the Regulation of LDTs

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

Medtronic Launches Advisa and Ensura SR MRI SureScan Pacemaker Systems in Europe

June 2, 2014 10:22 am | by Medtronic | News | Comments

Medtronic, Inc., today announced CE (Conformité Européenne) Mark and commercial launch of the Advisa and Ensura SR MRI SureScan single chamber pacemaker devices in Europe. Both pacemakers are approved for magnetic resonance imaging (MRI)...

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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. | Blogs | 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...

2nd Annual Medical Device Global Labeling Strategies Conference

May 30, 2014 9:29 am | Events

The 2nd Annual Medical Device Global Labeling Strategies Conference is a highly informative, content driven forum focusing on the key fundamentals for achieving a compliant global labeling process, including: preparing for UDI compliance...

Unique Device Identification: Three Steps to Compliance

May 29, 2014 9:59 am | by Nick Recht, Enterprise Product Manager, TEKLYNX Americas | Articles | Comments

In the medical device industry, accurate identification has never been more important. Failure to adhere to rules and regulations can be the difference between life and death for patients. Growing concerns about product recalls, counterfeit...

3D Printing a Healthcare Revolution

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

PCR Innovation Day Promotes Interaction Between Stakeholders in Cardiovascular Innovation

May 20, 2014 11:41 am | by EuroPCR | News | Comments

The first PCR Innovation Day focused on facilitating a constructive interaction between the key stakeholders—physicians, inventors, entrepreneurs, investors, start-ups, MedTech incubators, regulatory organisations and larger companies —in...

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Medtronic Announces CE Mark and Launch of NC Euphora Coronary Balloon

May 20, 2014 10:26 am | by Medtronic | News | Comments

Continuing its commitment to bringing advanced and clinically relevant interventional technologies to market, Medtronic, Inc. has announced CE (Conformité Européene) mark and launch of the NC Euphora Noncompliant Balloon Dilatation Catheter...

May 2014 Digital Edition

May 13, 2014 4:39 pm | by MDT Staff | Digital Editions | Comments

In May, there are three presentations that contribute to the cover focus of in vitro diagnostics. “RFID Enables a Clear Line of Sight to Time Savings” highlights the use of RFID to track compounds, chemicals, and reagents; while “The Role of Polymer...

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 | Blogs | 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...

FDA Allows Marketing of Prosthetic Arm that Translates Signals from Person’s Muscles

May 9, 2014 2:11 pm | by FDA | News | Comments

The U.S. Food and Drug Administration (FDA) today allowed marketing of the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG)...  

Strong Review Performance Brings Innovative Medical Products to Patients

May 8, 2014 3:38 pm | by Margaret A. Hamburg, M.D., Commissioner, FDA | Blogs | Comments

There are many ways FDA supports biomedical innovation as part of our mission to protect and promote public health. We are committed to finding ways to ensure that safe and effective products can get to the people who need them as swiftly...

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Recall Report: PT/INR Test Strips Had Significantly Innacurate Results

May 7, 2014 2:13 pm | by Food and Drug Administration (FDA) | News | Comments

Alere is recalling this product due to complaints of patients who had a therapeutic or near therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed...

FDA Approves BIOTRONIK Entovis Pacemaker System with ProMRI Technology

May 7, 2014 10:33 am | by The Associated Press | News | Comments

BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced today that the Food and Drug Administration (FDA) has granted approval for its Entovis pacemaker system with ProMRI ® technology. The Entovis system allows patients...

GHX Expands Unique Device Identification Solution with PTC

May 6, 2014 7:35 am | by The Associated Press | News | Comments

Developed in collaboration with the FDA and major medical device manufacturers, the PTC UDI solution generates the required Health Level 7 Structured Product Labeling-formatted submission data, transmits it to the FDA’s GUDID, and tracks FDA...

Recall Report: Door Assemblies in Infusion Pumps May Break

May 5, 2014 10:02 am | by Food and Drug Administration (FDA) | News | Comments

Hospira received customer reports of broken door assemblies on the Abbott Acclaim infusion pumps and the Hospira Acclaim Encore infusion pumps. When the door is closed properly, it helps ensure that the tubing is seated properly to ensure...

FDA Approves First-of-a-Kind Sleep Apnea Implant

May 1, 2014 11:18 am | by The Associated Press | News | Comments

Sleep deprived Americans have a new option to address hard-to-treat nighttime breathing problems: a first-of-kind device that keeps airways open by zapping them with an electrical current. The Food and Drug Administration approved the... 

Medtronic’s Viva Cardiac Resynchronization Therapy-Pacemaker Gains CE Mark

May 1, 2014 10:10 am | by Medtronic | News | Comments

Medtronic, Inc. has announced CE (Conformité Européenne) Mark receipt and the European launch of its newest cardiac resynchronization therapy-pacemaker, Viva CRT-P. The Viva CRT-P is not approved for sale in the United States. The Viva... 

Recall Report: Locking Mechanism in Ventricular Assist System May Fail

April 30, 2014 9:50 am | by Food and Drug Administration (FDA) | News | Comments

The company received reports where the driveline connector locking mechanism has failed to engage as a result of a faulty manufacturing assembly process. This failure could result in the pump stopping and potentially lead to serious adverse...

Aligning for Growth: The Evolution of Medical Device Labeling

April 28, 2014 2:06 pm | by PRISYM ID | White Papers

The introduction of Unique Device Identification (UDI) regulations signals a seismic shift in the labeling of medical devices. Over the past twenty years, the development of labeling solutions for the highly regulated devices sector has been a steady...

Overcoming Regulatory Challenges in Companion Diagnostics

April 28, 2014 10:07 am | by Richard Park, Contributing Editor | Blogs | Comments

For my occasional series of blogs examining various facets of the companion diagnostics market, I asked some IVD regulatory experts to share their thoughts and opinions on the current regulations for companion diagnostics. The following...

Regulatory Considerations and Revalidation Tests for Managing Change in Packaging Materials or Critical Supplies

April 25, 2014 11:35 am | by Stacey Drosner, Director of Regulatory Affairs, and Wendy S. Mach, Packaging Section Leader, BS, RM(NRCM), CQA(ASQ), Nelson Laboratories | Nelson Laboratories, Inc. | Blogs | Comments

In light of recent material changes within the medical device packaging industry, it is imperative manufacturers respond to triggers built into their change management process so they can (1) assess the impact a change in materials or processes...

FDA Approves First Human Papillomavirus Test for Primary Cervical Cancer Screening

April 25, 2014 9:56 am | by FDA | News | Comments

The U.S. Food and Drug Administration today approved the first FDA-approved HPV DNA test for women 25 and older that can be used alone to help a health care professional assess the need for a woman to undergo additional diagnostic testing...

Collaboration and Medical Countermeasures: Furthering Regulatory Science

April 24, 2014 2:31 pm | by Stephen Ostroff, M.D., Acting Chief Scientist, FDA | Blogs | Comments

“I hope no one ever needs these products,” isn’t something you hear too often, particularly from those developing drugs, biologics, or devices. That point of view—and a universal desire to protect the American public—is what sets biodefense....

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