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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...

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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...

World's First and Only Upgradeable Spinal Cord Stimulation System Receives FDA Approval

April 4, 2014 8:42 am | by The Associated Press | News | Comments

St. Jude Medical, Inc., a global medical device company, today announced the approval of its Protégé IPG from the U.S. Food and Drug Administration (FDA). Protégé is the first and only neurostimulation system that allows spinal cord stimulation...

Edwards Intuity Elite Valve System Receives CE Mark

April 4, 2014 3:36 am | by The Associated Press | News | Comments

Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, today announced it has received CE Mark for the advanced Edwards Intuity Elite valve system. This next-generation, rapid deployment...

5 Hidden Benefits of Your Trace Matrix: Make Better Decisions and Maximize Resources

April 3, 2014 2:36 pm | by Matt Harp, Product Marketing Director, Seapine Software | Articles | Comments

Your average traceability matrix is a complex document that gets little use or attention during the typical research and development process of a device. Then, at the end of the R&D cycle, you can spend days or even weeks compiling...

FDA Wants Your Perspective on Clinical Trial Demographic Data

March 31, 2014 10:38 am | by Jonca Bull, M.D., Director of Office of Minority Health, FDA | Blogs | Comments

When designing clinical trials, it is essential to test the safety and effectiveness of medical products in the people they are meant to treat. Although FDA’s policies, guidances, and regulations reflect decades of agency efforts to foster...

Committee Developing Proposed Standard for Unicondylar Knee Joint Replacements

March 28, 2014 10:45 am | by ASTM International | News | Comments

A proposed new ASTM International standard will cover fatigue testing of metallic tibial trays, which are components used in partial knee joint replacement. ASTM WK45235, Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components...

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