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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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Exploring the Environment of an Explosion

April 24, 2013 9:53 am | by Georgia Tech | Videos | Comments

To study the effects of improvised explosive devices on soldiers and help provide continuing treatment, Georgia Tech Research Institute (GTRI) researchers have developed IBESS, a sensor system that measures the physical environment of an explosion and collects data that can correlate what the soldier experienced with long-term outcomes.

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A Non-Invasive Breath Test for Lung Cancer

April 24, 2013 9:18 am | by Dr. John Cormier, Picomole | News | Comments

Picomole has announced that it has developed a diagnostic test to detect lung cancer that has a preliminary accuracy of 98.5%. This best-in-class result is better than any other technique currently in use for the detection of lung cancer, according to the company.

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Treatment Adherence Emerging as Critical Theme in Improving Quality and Cost of US Healthcare

April 24, 2013 6:21 am | by PR Newswire | News | Comments

As leaders across business, policy and academia gathered at the recent World Health Care Congress (WHCC) to discuss ways to improve the quality and cost of healthcare, experts in treatment adherence identified a common theme: a patient-centric adherence strategy will be critical to achieving success.

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Consumer Information on: DePuy Ceramax Ceramic Total Hip System - P070026S004

April 24, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

This is a brief overview of information related to FDA’s approval to market this product.  See the links to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

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Questions over Gene Patents Shake Diagnostics Industry

April 24, 2013 12:00 am | by Massachusetts Institute of Technology | News | Comments

At this week’s Biotechnology Industry Organization show in Chicago, a panel of law experts bemoaned the recent Supreme Court hearings on whether individual genes can be patented, saying there was no sign that anyone involved in the case truly understood the technology or the business implications of their arguments.

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Millstone Medical Outsourcing Expands Medical Device Distribution Services

April 23, 2013 6:05 pm | by PR Newswire | News | Comments

Millstone Medical Outsourcing announced today that the company will offer customers an expanded medical device distribution service, which includes the ability to distribute directly to patients and to provide wholesale distribution to distributors, hospitals, and sales representatives.

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