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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 ...

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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...

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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...

M&A Slowdown and Drop in FDA Approvals Stifles Growth of Medtech Sector in 2013

March 11, 2014 4:47 pm | by EP Vantage | News | Comments

At the half-year mark, the medtech sector was on course for its worst year in a decade in terms of M&A activity, EP Vantage concluded last fall in its Half Year Review 2013 report. Unfortunately, the second half of the year showed little...

What’s New in the FDA’s 2015 Budget?

March 10, 2014 3:41 pm | by William Tootle, Director – Office of Budget, FDA | Blogs | Comments

A few days ago, President Obama released his Fiscal Year 2015 Budget Message to Congress, which included a high-level summary of his proposed funding for the FDA. Today the White House is out with the full budget, complete with all of the...

AdvaMed Statement on President's FY 2015 Budget Proposal

March 6, 2014 11:31 am | by AdvaMed | News | Comments

The Advanced Medical Technology Association (AdvaMed) released the following statement by Stephen J. Ubl, president and CEO, in response to the President’s FY 2015 budget proposal. “We applaud the additional funding to support high-technology...

Importers of Medical Devices to EU Must Comply with RoHS as of July 22, 2014

March 4, 2014 10:56 am | by TÜV Rheinland | News | Comments

Manufacturers whose medical products are imported to the European Union (EU) will need to comply with the environmental directive, Restriction of Hazardous Substances (RoHS), as of July 22, 2014. Often called the “lead-free” directive, RoHS...

Why Should an IVD Manufacturer Consider ISO 13485 Certification?

March 3, 2014 5:33 pm | by Sarah Stec, Esq., Legal and Regulatory Director, GMED North America Inc. | Articles | Comments

In vitro diagnostic medical devices, or IVDs, are critical medical devices that can be used to help the patient, physician, and caregiver in reaching medical decisions. Their growing influence and added value in the worldwide medical device...

AdvaMed Statement on FDA 510(k) Report to Congress

February 27, 2014 11:45 am | by AdvaMed | News | Comments

Janet Trunzo, senior executive vice president, technology and regulatory affairs, for the Advanced Medical Technology Association (AdvaMed), issued the following statement in response to FDA’s report to Congress on requirements for submitting...

Exporting Medical Devices

February 27, 2014 11:37 am | by U.S. Food & Drug Administration | News | Comments

The rules that companies must follow when exporting medical devices depend on whether or not their devices have been approved or cleared by the Food and Drug Administration. Medical devices that are legally marketed in the U.S. may be exported...

Covidien Announces 510(k) Clearance for the Puritan Bennett 980 Ventilator

February 27, 2014 9:29 am | by Business Wire | News | Comments

Covidien plc, a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, today announced its Puritan Bennett 980 ventilator has received U.S. Food and Drug Administration...

Republicans Blast FDA Monitoring of Whistleblowers

February 26, 2014 12:06 pm | by The Associated Press | News | Comments

Republicans are blasting the Food and Drug Administration for secretly monitoring the emails of agency scientists who went public with allegations that they were pressured to approve certain medical devices. In a report published Tuesday...

Premarket Approval Update for AEDs and Accessories

February 25, 2014 2:38 pm | by Jeff Lind, President, Compliance West, and Jamie Young, Operations Manager, CALM Technologies | Compliance West USA | Blogs | Comments

Manufacturers of AEDs and accessories take notice: By docket number FDA-2013-N-0234, the FDA is considering requiring a premarket approval application or notice of completion of a product development protocol for AED systems and accessories...

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