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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)...  

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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...

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...

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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...

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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....

FDA Proposes Expedited Access Program for Devices that Address Unmet Medical Needs

April 22, 2014 2:46 pm | by FDA | News | Comments

The U.S. Food and Drug Administration proposed a new program to provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious conditions whose medical needs are unmet by current technology...

Intuitive Surgical’s da Vinci Sp System Earns FDA Clearance

April 22, 2014 9:55 am | by Globe Newswire | News | Comments

Intuitive Surgical, Inc., the global leader in robotic-assisted minimally invasive surgery, has announced it has received FDA 510(k) clearance for the da Vinci Sp Surgical System, which is designed to expand the Company's single-incision...

Bar Code Labeling and Traceability Modules

April 22, 2014 8:10 am | by MDT Staff | Product Releases | Comments

SYSCON-PlantStar, a provider of Manufacturing Execution Systems for Plastics Processing and related industries, has released advancements to its Bar Code Labeling and Traceability Modules in its suite of production and process monitoring products...

FDA Works with China to Ensure Medical-Product Safety

April 18, 2014 8:02 am | by Christopher Hickey, Ph.D., Country Director for the People’s Republic of China, FDA | Blogs | Comments

Americans benefit greatly from medical products produced by other countries. Approximately 40 percent of finished drugs in the United States come from overseas, as well as more than 50 percent of all medical devices. About 80 percent of the...

FDA Warns of Cancer Risk with Fibroid Procedure

April 17, 2014 4:41 pm | by Matthew Perrone - AP Health Writer | News | Comments

The Food and Drug Administration is warning women that a surgical procedure to remove noncancerous growths from the uterus could inadvertently spread cancer to other parts of the body. The agency is discouraging doctors from performing the...

GS1 Healthcare Releases UDI Implementation Guideline

April 16, 2014 11:17 am | by GS1 Healthcare | News | Comments

GS1 Healthcare US has published an implementation guideline for using GS1 Standards to address the U.S. Food and Drug Administration’s new regulation for Unique Device Identification (UDI). The guideline, titled “Using the GS1 System for FDA..

FDA Seeks Comment on Proposed Health IT Strategy that Aims to Promote Innovation

April 15, 2014 2:28 pm | by Bakul Patel, Senior Policy Advisor, CDRH | Blogs | Comments

Health information technology (IT) offers many benefits to the American people and health care providers. Health IT products, technologies and services can prevent medical errors, improve efficiency and health care quality, reduce costs...

Covidien Gets FDA 510(k) Clearance for Kangaroo Feeding Tube with IRIS Technology

April 14, 2014 11:20 am | by Covidien | News | Comments

Covidien today announced U.S. Food and Drug Administration 510(k) Clearance for the Kangaroo feeding tube with IRIS Technology. This first-of-its-kind camera-equipped disposable feeding tube is designed to enhance patient safety by providing...

Syneron Receives US FDA Clearance to Market the UltraShape System for Fat Cell Destruction

April 14, 2014 9:23 am | by The Associated Press | News | Comments

Syneron Medical Ltd., a global market leader in the aesthetic medical device marketplace, announced today that it has received the United States Food and Drug Administration (FDA) 510(k) clearance to market the UltraShapeT System for non...

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