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Common Condiment Could Enable New High-Tech Industry

August 9, 2013 12:12 pm | by Oregon State University | Comments

Chemists at Oregon State University have identified a compound that could significantly reduce the cost and potentially enable the mass commercial production of silicon nanostructures – materials that have huge potential in everything from electronics to biomedicine and energy storage.

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Robotic Intubation Prototype Crawls to the Lungs in Difficult Situations

August 9, 2013 11:55 am | by Hebrew University of Jerusalem | Comments

Graduates of the Hebrew University’s Biodesign program revealed a robotic intubation device that automatically identifies the lungs using an infrared source and navigates toward it. The device was successfully tested on cadavers at Hadassah Medical Center, and clinical trials will begin as soon as next year.

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Boston Scientific prices $1B debt offering

August 9, 2013 11:37 am | by Mass Device | Comments

Boston Scientific said it plans to use the proceeds of a $1.05 billion debt offering to retire some of its other debt coming due over the next few years. The Natick, Mass.-based medical device company said it will offer $600 million worth of 2.65% senior notes due Oct. 1, 2018, and another $450 million worth of 4.125% notes due Oct. 1, 2023.

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George W. Bush Heart Surgery Will Drive Misguided US Stenting Trend, Says GlobalData

August 9, 2013 11:30 am | by GlobalData | Comments

Former President George W. Bush’s recent heart stent operation will further increase the popularity of what is often an unnecessary and wasteful procedure, says an analyst with research and consulting firm GlobalData. The ex-US President received a stent to prop open a clogged coronary artery on Tuesday morning, following a regularly scheduled visit to his doctor.

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Robot Uses Steerable Needles to Treat Brain Clots

August 9, 2013 10:38 am | by David Salisbury | Comments

Surgery to relieve the damaging pressure caused by hemorrhaging in the brain is a perfect job for a robot. That is the basic premise of a new image-guided surgical system under development at Vanderbilt University. It employs steerable needles about the size of those used for biopsies to penetrate the brain with minimal damage and suction away the blood clot that has formed.

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RTI Surgical™ Announces Launch of Tritium™ Sternal Cable Plating System

August 9, 2013 9:00 am | by Business Wire | Comments

RTI Surgical Inc. has announced today the full market launch of the Tritium Sternal Cable Plating System for closing median sternotomies following open heart procedures. The Tritium SCP System enhances the stability and strength of traditional sternal closure techniques by using a unique load-sharing concept.

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A proverbial 'Disneyland Sweepstakes' in med device sends 1 company to AdvaMed 2013

August 9, 2013 7:59 am | by Mass Device | Comments

It's the proverbial "Disneyland Sweepstakes" in the medical device world: an all-expenses-paid trip to AdvaMed's 2013 conference will go to 1 start-up company through a scholarship contest sponsored by RCT BioVentures. The winner will have to prove true start-up chops - a company with a great technology but not a lot of walking-around money.

Heart attack survival rates higher in gyms, study says

August 9, 2013 7:29 am | by Mass Device | Comments

Surviving sudden cardiac arrest depends largely on the people around you and easy access to an automated defibrillator, or AED. It turns out that the gym is the best indoor location for cardiac arrest victims' survival chances, likely because of the increased presence of AEDs and well-placed instruction manuals.

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An Electric Therapy for Medical-Device Malware

August 9, 2013 12:00 am | by Massachusetts Institute of Technology | Comments

Hospital rooms beep and flash with many devices that are increasingly getting infected with malware. But for several reasons, these gadgets are often incompatible with commercial security software. Now, new technology developed by academic researchers could catch most malware on the devices just by noting subtle changes in their power consumption.

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Upcoming IDE Tracking Improvements

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

Improving patient access to new medical devices by strengthening and streamlining the clinical trial enterprise is a priority for CDRH. An important part of reaching that goal is to better track milestones in clinical trial development, Investigational Device Exemption (IDE) approval, study initiation, and study completion. 

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PMA Final Decisions for May 2013

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

Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis. A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA.

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Verizon Gains FDA Clearance for Remote Health Monitoring Solution

August 8, 2013 4:15 pm | by PR Newswire | Comments

Verizon announced today that it has received U.S. Food and Drug Administration 510(k) clearance for Converged Health Management, a cloud-based, remote patient-monitoring medical device.  This marks the first time Verizon has sought and gained FDA clearance for a healthcare solution.

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Frost & Sullivan: Technology as a Competitive Differentiator Fuels Adoption of Electronic Medical Records in Brazilian Hospitals

August 8, 2013 3:59 pm | by PR Newswire | Comments

Intensifying competition among private hospitals in Brazil has compelled them to use advanced clinical systems as a market differentiator, thereby driving the uptake of electronic medical records (EMR). The need to reduce expenses in both public and private hospitals has further fuelled EMR installations in the country.

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FDA Approves First Rapid Diagnostic Test to Detect both HIV-1 Antigen and HIV-1/2 Antibodies

August 8, 2013 3:13 pm | by Food and Drug Administration | Comments

The U.S. Food and Drug Administration today approved the first rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens.

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Zimmer owes Stryker $210M for willful infringement

August 8, 2013 1:31 pm | by Mass Device | Comments

Zimmer is on the hook for more than $210 million in damages owed to rival Stryker, after a federal judge in Michigan tripled a jury's $70 million decision. Kalamazoo, Mich.-based Stryker sued orthopedics rival Zimmer in December 2010, alleging infringement of 3 patents covering wound debridement technology with Zimmer's Pulsavac Plus device.

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