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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...

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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...

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...

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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...

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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...

FDA Approval for First Catheter Ablation Therapy in the U.S. with Direct Contact Force Technology

February 25, 2014 10:46 am | by Business Wire | News | Comments

Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced that it has received approval from the United States Food and Drug Administration (FDA) for its THERMOCOOL SMARTTOUCH Catheter... 

New Breast Implant Recall in the EU Prompts Need for VeriTeQ’s Device Traceability Technology

February 24, 2014 9:16 am | by The Associated Press | News | Comments

VeriTeQ Corporation, a provider of implantable medical device identification and radiation dose measurement technologies, today commented on the latest breast implant recall in the European Union. Breast implants manufactured by French company...

Second 510(k) Premarket Notification for the Paragonix Sherpa Cardiac Transport System

February 24, 2014 6:14 am | by The Associated Press | News | Comments

Paragonix Technologies, Inc. today announced that it has received clearance for its second Premarket Notification (510(k)) with the US Food and Drug Administration for its Paragonix Sherpa Pak Cardiac Transport System. The Sherpa Pak Cardiac...

Survey Reveals Real World Impact of Medical Device Tax

February 21, 2014 12:22 pm | by AdvaMed | News | Comments

The Advanced Medical Technology Association (AdvaMed) has released new survey results examining the first-year impact of the medical device excise tax. The survey found a significant reduction in jobs, R&D, and U.S. investment. To...

Boston Scientific Esophageal Stent Gains CE Mark

February 19, 2014 10:15 am | by PRNewswire | News | Comments

Boston Scientific Corporation has received CE Mark in Europe for its WallFlex Esophageal Fully Covered Stent to treat refractory benign esophageal strictures. Benign esophageal strictures are a narrowing of the esophagus caused by scar tissue...

Editorial Guidance

February 18, 2014 1:49 pm | by Sean Fenske, Editor-in-Chief | Blogs | Comments

I’m pleased to introduce the members of MDT’s first editorial advisory board. Representing the industry from supplier to medical device OEM to consultant, I’ve reached out to these individuals to help me tailor the scope of MDT’s editorial...

FDA Accreditation Terminology – Magic or Misdirection?

February 18, 2014 10:06 am | by Dr. Byron Osing, CEO & Chair, Calgary Scientific | Blogs | Comments

Have you ever watched a really good magician? It is incredible the tricks they can create before your very eyes and you are left amazed with the performance. When it comes to reviewing technology in the medical industry, you also have to be...

Obamacare Boosts U.S. Market for Sub-Acute COPD Ventilators

February 13, 2014 3:19 pm | by IHS | News | Comments

Spurred by cost-reduction efforts under the Affordable Care Act (ACA), U.S. shipments of ventilators used for hospital patients undergoing sub-acute treatment for chronic obstructive pulmonary disease (COPD) will rise by more than ...     

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