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Potential for Delivery System Catheter Separation Prompts Cook Medical To Initiate Voluntary Global Recall of Zilver® PTX® Drug Eluting Stent

April 24, 2013 4:40 pm | by The Associated Press | News | Comments

Based on its investigation into a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter, Cook Medical has initiated a nationwide/global voluntary recall of its Zilver® PTX® Drug Eluting Peripheral Stent.

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Life Care Medical Devices Ltd Announces CE Mark And Planned Commercialization For Laparoscopic Surgery Access Device

April 24, 2013 4:29 pm | by The Associated Press | News | Comments

Life Care Medical Devices Ltd today announced the issuance in August 2012 of CE mark for its Keyhole Cup Laparoscopic Access Device. Keyhole Cup addresses a critical need in the laparoscopic surgery market and was developed to advance the standard of care for laparoscopic access.

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FDA Grants Clearance for Biomedical Electrical Safety Analyzer

April 24, 2013 4:14 pm | by MDT Staff | Product Releases | Comments

The United States Food and Drug Administration (FDA) announced today it has granted Fluke Biomedical clearance for the new automated, multifunctional ESA615 Electrical Safety Analyzer 510(k). Now, medical device quality and safety professionals can test to the newest safety standards in just minutes, using this all-in-one automated test tool.

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Embedded Wireless Portfolio

April 24, 2013 3:40 pm | by MDT Staff | Microchip Technology Inc. | Product Releases | Comments

Microchip Technology announced a major expansion of its embedded-wireless portfolio from the DESIGN West/Embedded Systems Conference in San Jose. The Bluetooth additions include the PIC32 Bluetooth Audio Development Kit, featuring modules, stacks and CODECs, and XBee footprint-compatible socket modules with integrated stacks.

Vascular Solutions can't dodge illegal marketing lawsuit

April 24, 2013 3:11 pm | by Mass Device | News | Comments

Minnesota medical device maker Vascular Solutions (NSDQ:VASC) wasn't able to dodge a federal off-label marketing lawsuit over its Vari-Lase varicose vein treatment devices, the company revealed in its latest financial report. A Texas court ruled last month against Vascular Solutions' motion to dismiss a U.S. Attorney's Office complaint...

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UIC Building $3.4M Bioscience Research Facility

April 24, 2013 2:50 pm | by The Associated Press | News | Comments

Officials have announced a new $3.4 million bioscience research facility at the University of Illinois at Chicago. The 12,000-square-foot facility is being built with state capital funds and money from UIC. Gov. Pat Quinn and UIC officials announced the facility on Wednesday at the proposed site.

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FDA's next-gen medtech surveillance bets heavily on unique device identifiers

April 24, 2013 1:47 pm | by Mass Device | News | Comments

The FDA laid out plans to revamp its postmarket surveillance of medical devices, and a large part of that has to do with finalizing and implementing a long-awaited Unique Device Identifier program to better track and monitor devices. The federal watchdog agency aims this year to finalize a UDI rule...

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Medical device tax: Sen. Max Baucus's retirement and its effect on repeal

April 24, 2013 12:57 pm | by Mass Device | News | Comments

It's unlikely that his waning days as chairman of the Senate Finance Committee will see Sen. Max Baucus (D-Mont.) having a "Come-to-Jesus" moment on the medical device tax, but his retirement does change the game on repealing the levy.

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Medical device tax helps push Spectranetics further into the red in Q1

April 24, 2013 12:49 pm | by Mass Device | News | Comments

Colorado-based medical device maker Spectranetics (NSDQ:SPNC) broke out the red ink in 2013, blaming the swing partly on the newly implemented medtech excise tax, which requires that companies pay a 2.3% levy on all U.S. sales of applicable medical devices.

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NeuroMetrix to Partner with Omron Healthcare for Distribution of NC-stat DPNCheck in Japan

April 24, 2013 11:32 am | by The Associated Press | News | Comments

WALTHAM, Mass.--(BUSINESS WIRE)--Apr 24, 2013--NeuroMetrix, Inc. (Nasdaq: NURO), a medical device company focused on the treatment of diabetic peripheral neuropathy (DPN), announced that it had entered into an agreement with Omron Healthcare Co., Ltd. to be the exclusive distributor for NC-stat ®...

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Texas Institute for Robotic Surgery Among First in Nation To Perform Single-Site Robotic Hysterectomy Surgery

April 24, 2013 10:53 am | by PR Newswire | News | Comments

AUSTIN, Texas, April 24, 2013 /PRNewswire/ -- The Texas Institute for Robotic Surgery at St. David's North Austin Medical Center recently became one of the first facilities in the nation to perform a hysterectomy using a new single-site platform for robotic surgery.

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Why New Inspection Methods Can Cost Less

April 24, 2013 10:36 am | by Steve Heveron-Smith, VP of Business Development and Marketing, Lumetrics | Lumetrics Inc. | Articles | Comments

This article describes the challenges and successes in which a modern, non-contact technology replaced older manual methods. Four scenarios are discussed in which this newer technology can be integrated into a company’s process: new product development, process improvements, problem resolution, and existing products.

Is a Hacked Pacemaker Capable of Mass Murder?

April 24, 2013 10:23 am | by Kasey Panetta, Managing Editor, ECN | Blogs | Comments

When you are a patient in a hospital, you tend to expect that the electronics are either top of the line or at least functioning correctly. You expect that the devices doctors implant in your body are reliable and safe. These seem like safe assumptions. Unfortunately, you could be mistaken.

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Z-Medica Announces Expanded CE Indications for QuikClot Hemostatic Dressings Supporting Broader Use in Surgical Wound Care

April 24, 2013 10:07 am | by PR Newswire | News | Comments

WALLINGFORD, Conn., April 24, 2013 /PRNewswire/ -- Z-Medica®, a leading developer and marketer of hemostatic agents, announced newly expanded CE indications for QuikClot® Hemostatic Dressings today. The expanded indications support the use of QuikClot® products as an...

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Sensor System to Assess the Effects of Explosions on Soldiers

April 24, 2013 9:59 am | by T.J. Becker, Georgia Tech | News | Comments

Improvised explosive devices (IEDs) are becoming a global problem for the U.S. armed forces. To prevent injuries to soldiers and provide better care to those who are injured, the U.S. military is striving to better understand how blasts impact the human body.

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