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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...

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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....

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...

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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..

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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...

Unique Device Identification – A Turning Point for Healthcare

April 11, 2014 3:44 pm | by Michael Pheney, Vice President of Healthcare, GS1 US | Articles | Comments

For decades, the U.S. healthcare industry has struggled to overcome problems caused by bad or conflicting data in its supply chain, including multiple, differing or proprietary descriptions of medical/surgical products. The negative ripple...

Spectranetics Announces FDA Clearance for Mechanical Lead Extraction Devices

April 11, 2014 10:02 am | by Globe Newswire | News | Comments

The Spectranetics Corporation today announced FDA clearance of two new mechanical lead extraction platforms that expand physicians' options for safe removal of cardiac leads. Each incorporates innovative designs for mechanical extraction...

Baxano Surgical Receives 510(k) Clearance for the Avance MIS Pedicle Screw System

April 11, 2014 9:41 am | by Globe Newswire | News | Comments

Baxano Surgical, Inc., a medical device company focused on designing, developing and marketing minimally invasive products to treat degenerative conditions of the lumbar spine, today announced that it has received U.S. Food and Drug...   

Medtronic CRT Devices Now Approved to Treat Patients with AV Block and Reduced Heart Function

April 10, 2014 7:33 pm | by The Associated Press | News | Comments

Medtronic, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for biventricular (BiV) pacing with Medtronic cardiac resynchronization therapy-pacemakers and -defibrillators (CRT-P and CRT-D)...

GE Healthcare Receives FDA Clearance For Q.Clear Technology

April 8, 2014 9:34 am | by PR Newswire | News | Comments

GE Healthcare, a unit of General Electric Company, has announced that it received U.S. FDA 510(k) clearance of its Q.Clear technology – technology that can provide up to two times improvement in both quantitative accuracy and image quality...

CardiacAssist Receives Health Canada Approval for Its TandemHeart Circulatory Support Platform

April 8, 2014 8:30 am | by The Associated Press | News | Comments

CardiacAssist, Inc., a privately-held medical device company headquartered in Pittsburgh, Pennsylvania, today announced that it has received a Class 4 medical device license for its TandemHeart System from Health Canada. The TandemHeart...

Mitralign Completes Enrollment in EU Study for its Novel Catheter-based Valve Repair Device

April 8, 2014 8:30 am | by The Associated Press | News | Comments

Mitralign Inc., a cardiac device company, announced today it has completed enrollment in a study in Europe investigating its lead device, the Mitralign System, in patients with functional mitral regurgitation (FMR). Pending successful outcomes...

Boston Scientific's Endoscopic Ultrasound Needle Is for Use During Fine Needle Aspiration Procedures

April 7, 2014 6:31 pm | by PR Newswire | News | Comments

Boston Scientific Corporation has received clearance from the U.S. Food and Drug Administration (FDA) and CE Mark approval in Europe for the Expect™ Slimline (SL) Needle, which is now globally available for Endoscopic Ultrasound-Fine Needle...

Calgary Scientific Receives FDA Clearance for Mobile Diagnosis on all Modalities

April 7, 2014 8:22 am | by The Associated Press | News | Comments

Calgary Scientific Inc., a company known for creating transformative technology for the medical industry and beyond, announced today their latest Class II clearance from the United States (US) Food and Drug Administration (FDA). The leading...

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