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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...

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 ...     


February 11, 2014 10:45 am | by SIIA | News | Comments

Senators Deborah Fischer (R-NE) and Angus King (I-ME) have introduced the Preventing Regulatory Overreach To Enhance Care Technology Act of 2014 (PROTECT Act), legislation to provide regulatory certainty for ...        

AdvaMed Releases Revised Registry Principles

February 5, 2014 11:49 am | by AdvaMed | News | Comments

The Advanced Medical Technology Association (AdvaMed) announced today the release of revised principles for the creation and maintenance of medical device registries. Approved by AdvaMed’s Board of Directors, the principles are intended...

Complying with Product Data Sharing Requirements Under UDI

February 4, 2014 2:03 pm | by Denise Odenkirk, Senior Director, Industry Solutions, GHX | Articles | Comments

In this article, we’ll examine the FDA’s product data sharing requirements under the UDI rule, the challenges most medical device manufacturers face in complying with this legislation, and factors medical device manufacturers should take...

Quantifying the FDA's Rulemaking Delays Highlights the Need for Transparency

February 4, 2014 12:15 pm | by Brigham and Women's Hospital | News | Comments

In a study published in Health Affairs on February 3, 2014, Aaron Kesselheim, MD, JD, MPH, and co-authors, quantify how long it takes the FDA to enact a formal rule affecting drugs, medical devices and other health-related products. The FDA...

Ellipse Technologies Receives FDA Clearance for Next Generation of Unique Limb Lengthening System

February 4, 2014 8:15 am | by The Associated Press | News | Comments

Global medical device company, Ellipse Technologies, Inc., has announced that it has received FDA marketing clearance of the PRECICE® 2 Intramedullary Limb Lengthening System in the United States. This marketing clearance represents the...

mHealth report: Apple execs met with FDA, too

February 3, 2014 12:39 pm | by Mass Device | News | Comments

Technology titan Apple Inc. sent a few executives to the FDA late last year to meet with agency officials to talk about "mobile medical applications," according to the FDA's public calendar. Representatives from Apple included senior vice...

Structure of Regulatory Affairs in Medical Device Companies Impacting Organizational Efficiency

January 31, 2014 6:30 pm | by PR Newswire | News | Comments

Ensuring that companies comply with the plethora of global regulations pertaining to developing and marketing new medical device products is a challenge faced by many organizations. To cope with these challenges, Regulatory Affairs groups...

New Developments in 2014 Bring Challenges for Designers

January 31, 2014 1:53 pm | by Mike Brousseasu, Manager — Safety Group, and Joe Langton, Business Service Line Leader — Chemical, Intertek | Blogs | Comments

In the coming year, medical device manufacturers will need to focus on getting their products compliant, available, and possibly re-designed to keep up with the ever-changing standards associated with the medical device industry. The Affordable...

Covidien Receives Japanese Regulatory Approval for Reinforced Stapling Reload Technology

January 27, 2014 5:11 pm | by The Associated Press | News | Comments

Covidien plc has announced that its Japanese subsidiary, Covidien Japan Inc., has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare for its Endo GIA Reinforced Reload with Tri-Staple technology. This approval...

Transforming the Medical Devices Industry Through Unique Device Identification

January 27, 2014 12:36 pm | by Rajeev Kapoor & Chris Paddison, A.T. Kearney | Articles | Comments

As consumers, of course, we’re all familiar with bar codes. But consider the profound transformations resulting from this universal product identifier. Today’s consumer-goods industries rely on bar code–powered innovations in inventory... 

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