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What's changing, what's not, in a shutdown

October 1, 2013 3:38 am | by Calvin Woodward - Associated Press | News | Comments

Campers in national parks are to pull up stakes and leave, some veterans waiting to have disability benefits approved will have to cool their heels even longer, many routine food inspections will be suspended and panda-cams will go dark at the shuttered National Zoo.

CareFusion Provides Update On Voluntary Recall Of AVEA® Ventilator

September 30, 2013 4:16 pm | by PR Newswire | News | Comments

The company initiated the voluntary recall on Sept. 3, 2013. The FDA has classified this action as a Class I recall. A Class I recall is defined as a reasonable probability of serious adverse health consequences or death associated with use of the defective units.

FDA Rule Mandating Unique Device Identification for Reusable Medical Devices Creates New Market Opportunity for VeriTeQ in Breast Implant Sizers and Other Reprocessed Devices

September 30, 2013 8:30 am | by Business Wire | News | Comments

Digital Angel Corporation, a provider of implantable medical device identification and radiation dose measurement technologies, following its recent share exchange with VeriTeQ Acquisition Corporation, discussed today a new market opportunity for identifying breast implant sizers, which was created, in part, by the FDA Final Rule for Unique Device Identification, announced on September 20, 2013.

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QPharma’s Medical Device Division Offers Guidance on UDI Final Rule

September 26, 2013 2:13 pm | by Business Wire | News | Comments

On Friday, September 20, the final Unique Device Identification (UDI) rule was issued by the Food and Drug Administration in conjunction with the 2013 UDI Conference in Baltimore, Maryland. Tom Beatty, Sr. Principal, UDI Compliance at QDevice, the medical device consulting division of QPharma, was in attendance for the announcement.

FDA Broadens Options for Using Edwards Heart Valve

September 24, 2013 11:45 am | by The Associated Press | News | Comments

The Food and Drug Administration said Monday that it has approved broader use of an innovative artificial heart valve that can be implanted without major surgery, allowing surgeons to insert the implant through multiple pathways. The agency approved revised labeling for Edwards Lifesciences' Sapien heart valve...

FDA Lays Out Rules for Some Smartphone Health Apps

September 24, 2013 11:38 am | by The Associated Press | News | Comments

Food and Drug Administration officials say they will begin regulating a new wave of applications and gadgets that work with smartphones to take medical readings and help users monitor their health. With the rise of the iPhone, Android and other mobile devices has come a flood of applications designed to help people stay healthy.

GS1 Standards Assist Manufacturers in Meeting New FDA Requirements for Unique Device Identification

September 24, 2013 9:03 am | by The Associated Press | News | Comments

GS1 Standards can help manufacturers comply with a new regulation released by the FDA that establishes a national unique device identification system for medical devices to increase patient safety. A new GS1 UDI resource Web page is now available to offer GS1 Standards implementation guidance.

Theorem Clinical Research Puts Medical Device Expertise on Display at Outsourcing in Clinical Trials New England

September 24, 2013 8:00 am | by Business Wire | News | Comments

Theorem Clinical Research, one of the leading CROs in the medical device arena, will be in Boston for the Outsourcing in Clinical Trials New England conference, Oct. 1-2 at the Westin Boston Waterfront in Boston. “A whole section of the agenda is devoted to medical devices and the industry-specific challenges sponsors face in gaining regulatory approval...

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FDA expands clearance for Intuitive Surgical's FireFly imaging system

September 23, 2013 2:27 pm | by Mass Device | News | Comments

Intuitive Surgical said the FDA expanded the 510(k) clearance for its FireFly fluorescence imaging system to use during gallbladder surgery using its da Vinci robotic surgery device. The device uses a video camera and fluorescent dye to show blood flow in vessels and tissue, by causing blood to appear green and bloodless tissue as gray, according to a press release.

FDA Releases Final Rule for Unique Device Identification

September 23, 2013 8:30 am | by Business Wire | News | Comments

Digital Angel Corporation, a provider of implantable medical device identification and radiation dose measurement technologies, following its recent share exchange with VeriTeQ Acquisition Corporation (“VeriTeQ”), announced today that the U.S. Food and Drug Administration (“FDA”) has released its Final Rule for Unique Device Identification (“UDI”).

FDA Requires Tracking Codes on Medical Implants

September 20, 2013 10:37 am | by The Associated Press | News | Comments

The Food and Drug Administration published new rules Friday that require most medical devices sold in the U.S. to carry a unique code, identifying its make, manufacture date and lot number. The codes will be stored in a publicly accessible database to help regulators, doctors and companies monitor safety issues with devices.

Sapheon Submits First Module of PMA Application for VenaSeal Sapheon Closure System

September 20, 2013 12:01 am | by The Associated Press | News | Comments

Sapheon Inc. announced today that it submitted the first module of the pre-market approval (PMA) application for the VenaSeal® Sapheon Closure System to the U.S. Food and Drug Administration (FDA). The submission places Sapheon on track for timely FDA review and expected product launch in the first half of 2015.

Keystone Heart’s TriGuard Cerebral Protection Device Receives CE Marking

September 19, 2013 10:50 am | by PR Newswire | News | Comments

The CE marked TriGuard is the only device designed to cover all three aortic cerebral branches to minimize the risk of cerebral damage during Transcatheter Aortic Valve Replacement (TAVR) and other cardiovascular procedures. It is the only system designed for placement via one of two femoral artery access ports.

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Cloud-Based Online Registration Platform Licensale.com Revolutionizes Medical Device Market

September 17, 2013 11:00 am | by PR Newswire | News | Comments

A case study released on the anniversary of medical device giant Elekta's work with Licensale.com revealed that just one year after its launch, Arazy Group's unique, online registration platform is a revolutionary regulatory asset for medical device manufacturers of all sizes.

New Regulations to Minimize Risk of Electromagnetic Interference

September 13, 2013 4:26 pm | by Ozgur Ozturk, Senior Business Manager, TUV Rheinland of North America | Tuv Rheinland Of North America | Articles | Comments

While all electronic products must comply with electromagnetic compatibility (EMC) requirements, EMC evaluation of medical devices is expanded to include product safety. This step-up is understandable as human health and life are frequently dependent on medical devices in a healthcare setting.

FDA panel: 30-year-old ECMO therapy should be reclassified to lower-risk Class II

September 13, 2013 3:49 pm | by Mass Device | News | Comments

An FDA panel yesterday recommended that the FDA reclassify membrane lung for long-term pulmonary support systems, or so-called extracorporeal membrane oxygenator circuits and accessories, from the highest-risk Class III category to the less burdensome Class II, with special controls.

FDA OKs implant for enlarged prostate symptoms

September 13, 2013 3:06 pm | by The Associated Press | News | Comments

Federal health regulators have approved the first permanent implant to treat men's urinary problems caused by an enlarged prostate. The Food and Drug Administration says it approved the Urolift system to relieve low or blocked urine flow in men age 50 or older.

FDA/American Gastroenterological Association (AGA) Co-sponsored Public Workshop: Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Metabolic Diseases, October 17-18, 2013

September 12, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The Food and Drug Administration (FDA) is announcing the following public workshop entitled "Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Metabolic Diseases:  How to Estimate and Reward True Patient-Centric Value in Innovation.”

'Obamacare' Contractors Project Confidence

September 10, 2013 1:43 pm | by Ricardo Alonso-Zaldivar, Associated Press | News | Comments

Major contractors hooking up the internal plumbing of President Barack Obama's health care law projected confidence Tuesday that they will be ready to go by an Oct. 1 deadline, even though the system is still being tested. With just three weeks to go before new state health insurance markets launch, efforts are ongoing to reliably link up government agencies, the markets themselves and private health plans.

The New FDA Draft Guidance for Biocompatibility: What You Need to Know

September 9, 2013 2:27 pm | by Thor Rollins B.S. RM(NRCM), Biocompatibility Expert, Nelson Laboratories | Nelson Laboratories, Inc. | Blogs | Comments

In a draft guidance document, FDA has placed its summary of ideas regarding biocompatibility and possible changes that could eventually replace FDA G-95 Blue Book Memorandum #G95-1 on biocompatibility. The draft document has been out since April and is widely available, though it has not been formally released.

Meeting Announcement: October 8-9, 2013 Circulatory System Devices Panel of the Medical Devices Advisory Committee

September 9, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

On both days the committee will discuss, make recommendations, and vote on devices indicated for use in patients with heart failure (HF).  On October 8, 2013, the committee will discuss, make recommendations, and vote on information related to the premarket approval application regarding the expansion of indications supported by the BLOCK HF trial...

Is Robotic Surgery as Safe as It Seems?

September 6, 2013 10:26 am | by Johns Hopkins | News | Comments

Despite widespread adoption by hospitals of surgical robot technology over the past decade, a “slapdash” system of reporting complications paints an unclear picture of its safety, according to Johns Hopkins researchers. In a report published online in the Journal for Healthcare Quality...

Siemens' high-risk recall affects more than 78,000 antimicrobial tests

September 5, 2013 1:59 pm | by Mass Device | News | Comments

FDA regulators put their highest-risk Class I label on Siemens' (NYSE:SI) recall of more than 78,000 of its MicroScan Synergies plus and MicroScan rapID/S plus antimicrobial tests, warning that false test results could hinder patient care.  

ASTM Medical and Surgical Materials Committee Approves New Orthopedic Hip Implant Standard

September 5, 2013 12:09 pm | by ASTM International | News | Comments

A new ASTM International standard will provide a consistent method for analyzing hip stems used in hip replacement surgery. The new standard, ASTM F2996, Practice for Finite Element Analysis (FEA) of Nonmodular Metallic Orthopaedic Hip Femoral Stems, was developed by Subcommittee F04.22 on Arthroplasty, part of ASTM International Committee F04 on Medical and Surgical Materials and Devices.

July/August 2013 Digital Edition

August 27, 2013 5:07 pm | Digital Editions | Comments

Innovative control technology offers medical professionals and technicians the potential to do much more with diagnostic imaging equipment. “A New Dimension in Diagnostics,” this issue's cover story, looks at intuitive controls for radiological applications.

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