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Senate Chides Medicare for $70M in Over-Payments for MedTech

March 29, 2013 7:29 am | by Mass Device | News | Comments

Medicare has lost about $70 million in unrecoverable sums overpaid to makers of durable medical devices, according to a Health & Human Services Dept. report, and the Senate's Finance Committee isn't too pleased. A bipartisan coalition from the committee chastised Medicare regulators for allowing million of dollars to "go to waste without a serious effort to recover it...

Neuro Kinetics Releases New Version of VEST(TM) Control & Analysis Software

March 28, 2013 5:03 pm | by The Associated Press | News | Comments

Medical device manufacturer Neuro Kinetics, Inc., (NKI) will showcase the latest version of its VEST™ control and analysis software at the American Academy of Audiology's AudiologyNOW! 2013 conference next week in Anaheim, California. The...

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ResMed Takes Action to Enforce Patents

March 28, 2013 4:59 pm | by PR Newswire | News | Comments

ResMed, an innovator and pioneer in developing products for the treatment of sleep-disordered breathing and respiratory conditions, has filed parallel legal actions in the International Trade Commission (ITC) and in U.S. federal court to stop the infringement of ResMed patents.

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EDAP Receives U.S. FDA Filing Acceptance of Pre-Market Approval Application

March 28, 2013 4:45 pm | by GlobeNewswire | News | Comments

EDAP TMS SA, the global leader in therapeutic ultrasound, announced today that the U.S. Food and Drug Administration has provided a positive Filing Review Notification on the Company's Pre-Market Approval (PMA) application for its Ablatherm Integrated Imaging HIFU (High Intensity Focused Ultrasound) device for the treatment of low-risk, localized prostate cancer.

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How to Make a Computer from a Living Cell

March 28, 2013 4:02 pm | by Massachusetts Institute of Technology | News | Comments

If biologists could put computational controls inside living cells, they could program them to sense and report on the presence of cancer, create drugs on site as they’re needed, or dynamically adjust their activities in fermentation tanks used to make drugs and other chemicals. Now researchers at Stanford University have developed a way to make genetic parts that can perform the logic calculations that might someday control such activities.

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MicroRNA Detection on the Cheap

March 28, 2013 3:58 pm | by MIT | News | Comments

Current methods of detecting microRNA (miRNA) — gene-regulating molecules implicated in the onset of various diseases — can be time-consuming and costly: The custom equipment used in such tests costs more than $100,000, and the limited throughput of these systems further hinders progress.

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Purdue-Developed Technology Could Provide a Solution to Antibiotic-Resistant Bacteria, Save Lives

March 28, 2013 3:55 pm | by Purdue Research Park | News | Comments

Through the misuse and overuse of antibiotics, several types of bacteria have become resistant to drugs that were designed to kill them. The Centers for Disease Control and Prevention estimate that some of these "superbugs" are linked to tens of thousands of deaths in the United States annually, including 14,000 for C. difficile and 19,000 for MRSA.

BDC Laboratories Announces VDT-3600i Heart Valve Accelerated Wear Test System

March 28, 2013 3:37 pm | by The Associated Press | News | Comments

WHEAT RIDGE, Colo.--(BUSINESS WIRE)--Mar 28, 2013--Positive clinical outcomes continue to be reported by researchers worldwide with transcatheter aortic valve implantation (TAVI). Moreover, new technologies are in development and will, in the future, offer additional minimally invasive treatment...

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Intuitive Surgical Can't Dodge Robot-Assisted Surgery Training Lawsuit

March 28, 2013 3:19 pm | by Mass Device | News | Comments

A Washington judge this week threw out Intuitive Surgical's bid to dismiss a lawsuit claiming the company failed to provide doctors with sufficient training on the da Vinci robot-assisted surgical system. The lawsuit was filed by the family of Fred Taylor who in 2008 underwent prostate removal by a doctor using the da Vinci device without supervision.

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Varian Medical Systems Highlights Calypso® System and Other Technologies Designed to Help Reduce the Risk of Heart Disease after Radiotherapy for Breast Cancer

March 28, 2013 2:48 pm | by PR Newswire | News | Comments

PALO ALTO, Calif., March 28, 2013 /PRNewswire/ -- Varian Medical Systems (NYSE:VAR), the world leader in radiotherapy equipment and software, is highlighting its Calypso® System as a tool designed to help doctors reduce women's risk of developing heart disease years after...

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Wellsense Announces Study of The Map System Shows Improvement in Care of Hospital-Acquired Pressure Ulcers

March 28, 2013 2:26 pm | by Wellsense | News | Comments

Recent research published in WOUNDS , the most widely read, peer-reviewed journal focusing on wound care and wound research, demonstrates the potential to improve care for patients vulnerable to hospital-acquired pressure ulcers by using Wellsense’s MAPTM System, the first-ever continuous bedside pressure mapping system.

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The Medical Device Tax Rears Its Head in the Mass. Senate Special Election

March 28, 2013 2:22 pm | by Mass Device | News | Comments

U.S. Representative Ed Markey (D-Mass.) offered his support to opponents of the medical device tax, saying that, had he had the chance, he would have sided with the Senate majority in voting to repeal the levy. Markey, a long-time Bay State lawmaker, is hoping to make the jump from the House to the Senate, vying for upper chamber seat left behind by U.S. Secretary of State John Kerry.

Will Another Durata Failure Report Drag St. Jude Down?

March 28, 2013 1:31 pm | by Mass Device | News | Comments

Wall Street didn't move much on news of another insulation-related failure in St. Jude Medical's next-generation Durata defibrillator leads this week. The case report included a detailed analysis of an incident in which a Durata lead failed due to inside-out abrasion...

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Biotronik Lands CE Mark for MRI-Safe Iforia Defibrillator

March 28, 2013 12:37 pm | by Mass Device | News | Comments

Biotronik said it's planning a mid-year launch in Europe for its Iforia MRI-safe pacemaker now that EU regulators have given the device CE Mark approval. The German medical device company said the Iforia is the world's 1st ICD/CRT-D device using the DF4 connector to be approved for magnetic resonance imaging, according to a press release.

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FDA Makes Vascular Solutions' Catheter Valve Recall Class I

March 28, 2013 11:26 am | by Mass Device | News | Comments

The FDA slapped its most serious designation on the recall of hemostasis valves made by Vascular Solutions (NSDQ:VASC). The Minneapolis-based company last month recalled its Guardian II and Guardian II NC valves "due to a risk that air may be introduced into the device which may lead to an air embolism," according to the federal watchdog agency.

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