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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...

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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...

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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...

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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...

World's First Pacemaker Series with Event-Triggered IEGM Transmissions Gains CE Mark

March 28, 2014 10:40 am | by PresseBox | News | Comments

BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced CE approval for its new Eluna pacemaker series today. The new generation of pacemakers includes single and dual-chamber as well as cardiac resynchronization...

Using PET Scanning to Evaluate Therapies of Menkes Disease

March 27, 2014 4:03 pm | by Satoshi Nozaki, RIKEN | News | Comments

Researchers at the RIKEN Center for Life Science Technologies in Japan have used PET imaging to visualize the distribution in the body of copper, which is deregulated in Menkes disease, a genetic disorder, using a mouse model. This study lays the groundwork for PET imaging studies on ...

Sports Medicine Market to Remain Strong Says GlobalData

March 26, 2014 11:11 am | by GlobalData | News | Comments

Driven by the growing prevalence of sports injury, coupled with an ageing population, the global arthroscopic implants market value will increase from $2.2 billion in 2013 to $3.4 billion by 2020, at a Compound Annual Growth Rate (CAGR) of 6.09%, says a new report from ...

Nanotube Coating Helps Shrink Mass Spectrometers

March 26, 2014 11:03 am | by Elizabeth K. Gardner, Purdue University | News | Comments

Nanotechnology is advancing tools likened to Star Trek's "tricorder" that perform on-the-spot chemical analysis for a range of applications including medical testing, explosives detection and food safety. Researchers found that when paper used to collect a sample was coated with carbon nanotubes, the voltage required ...

Sentinel: Harnessing the Power of Databases to Evaluate Medical Products

March 18, 2014 2:24 pm | by Michael D. Nguyen, MD, Acting Director of the Division of Epidemiology, FDA’s Center for Biologics Evaluation and Research | Blogs | Comments

Clinical trials are designed to evaluate the safety and effectiveness of medications. But the number of participants in clinical trials represents only a fraction of the number of people who will ultimately use the product after FDA approves...

European Post-Approval Trial for St. Jude's Leadless Pacemaker Begins

March 18, 2014 8:26 am | by The Associated Press | News | Comments

St. Jude Medical, Inc., a global medical device company, today announced the first enrollments in the company’s LEADLESS Pacemaker Observational Study evaluating the Nanostim™ leadless pacing technology. The Nanostim pacemaker received CE...

How to CE Mark Your Product

March 13, 2014 4:37 pm | by Newbury Electronics | White Papers

The CE Marking process tends to be complicated and time consuming. This white paper offers straight forward and easy to understand steps to successful CE marking. From this guide you will learn; why CE marking is easier than you think, an 11...

China in Your Hands: Grasping the Potential of Emerging Markets

March 13, 2014 3:23 pm | by Vince Postill, SVP of Global Business Development, PrisymID | Blogs | Comments

In 2011, China officially became the third biggest pharmaceutical market in the world – almost 50% bigger than fourth-placed Germany. Brazil, meanwhile, overtook mature European markets such as the UK, Italy and Spain, to climb to sixth place...

FDA Approves First ICD to be Evaluated in US Clinical Trials for Use in MRIs

March 13, 2014 12:31 pm | by The Associated Press | News | Comments

BIOTRONIK, a leading manufacturer of cardiovascular medical devices, announced today that the Food and Drug Administration (FDA) has approved the expansion of BIOTRONIK’s ongoing ProMRI trial. The new phase of the trial (Phase C) will study...

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