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Photos of the Day: SOFs for Biomimetics

December 17, 2013 11:27 am | by Lawrence Berkeley National Laboratory | Comments

Researchers with the U.S. Department of Energy’s Lawrence Berkeley National Laboratory have unveiled the first two-dimensional SOFs that self-assemble in solution, an important breakthrough that holds implications for sensing and separation...

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CE Mark and First Implants of Boston Scientific’s X4 Quadripolar CRT-D Systems

December 17, 2013 10:02 am | by PR Newswire | Comments

Boston Scientific Corporation has received CE Mark approval of its X4 line of quadripolar CRT-D systems, including the AUTOGEN X4, DYNAGEN X4, and INOGEN X4 cardiac resynchronization therapy defibrillators (CRT-Ds), a suite of ACUITY X4... 

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Report: Success of Vaccines Won’t Limit IVD Market

December 17, 2013 9:39 am | by Kalorama Information | Comments

Vaccines have been successful in preventing disease, but according to Kalorama Information that doesn’t mean they will hurt the market for products to test for those diseases. The healthcare market research publisher says a variety of factors...

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FDA OKs eNeura's novel migraine pain treatment stim

December 17, 2013 9:29 am | by Mass Device | Comments

Medtech maker eNeura Therapeutics won FDA clearance to market its 1st-of-its-kind Cerena transcranial magnetic stimulator, landing regulatory approval through the agency's less-stringent de novo premarket review pathway. The Cerena TMS is...

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SynCardia raises $14M for smaller total artificial heart

December 17, 2013 9:28 am | by Mass Device | Comments

SynCardia said it brought in another $14 million funding round, led by a $10 million contribution from SWK Holdings, that it plans to use to develop a smaller version of its total artificial heart. Tucson-based SynCardia said Athyrium Capital...

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Tektronix Donates Equipment to Edison Nation Medical to Further Health Care Innovation

December 17, 2013 9:00 am | by The Associated Press | Comments

Since its founding in 1946, Tektronix has been at the forefront of electronics innovation as the world's leading manufacturer of oscilloscopes - electronic test instruments that measure electrical signal changes. Now, Tektronix is continuing...

NuVasive(R) Announces the U.S. Launch of ALIF ACR(TM)

December 17, 2013 8:39 am | by The Associated Press | Comments

NuVasive, Inc., a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, is excited to announce the United States launch of ALIF ACR™ (Anterior Lumbar Interbody Fusion - Anterior...

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Kansas City Dentist Launches Healthcare Scrubs Line

December 17, 2013 7:33 am | by Bio-Medicine.Org | Comments

TiScrubs today announced the launch of its new line of healthcare scrubs. TiScrubs fill an unmet need in the medical apparel landscape by combining athletic materials with the utility of antimicrobial and hydro-wicking properties. Founder and...

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The 3D medical printing revolution

December 17, 2013 7:29 am | by Mass Device | Comments

New 3D printing technology has captured imaginations from NASA labs to art studios, but so-called "bio-printing" may be the revolution with the greatest direct human impact. San Diego, Calif.-based Organovo Holdings' bio-printer is making...

Total Artificial Heart Manufacturer SynCardia Secures $14M in Growth Financing

December 17, 2013 6:00 am | by The Associated Press | Comments

Privately held SynCardia Systems, Inc. announced today that it had raised $14 million to fund the rapid growth of the only approved medical device that eliminates the symptoms and source of end-stage heart failure, the SynCardia temporary...

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Paragonix Technologies Files 510(k) Application for Kidney Transporter

December 17, 2013 6:00 am | by Business Wire | Comments

Paragonix Technologies, Inc. today announced that it has successfully completed filing of a Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration for its Sherpa Pak Transporter. The Sherpa Pak Transporter...

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Overview of Medical Device Classification and Reclassification

December 17, 2013 12:00 am | by U.S. Food & Drug Administration | Comments

On July 9, 2012, Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA). Section 608(c) of FDASIA requires the FDA to annually post the number and type of medical devices reclassified in the previous calendar...

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Medical Device Reclassification

December 17, 2013 12:00 am | by U.S. Food & Drug Administration | Comments

As experience and knowledge about a device increase, the original classification of a device can be changed through reclassification. Two reclassification processes for medical devices described in the Food Drug and Cosmetic Act are explained...

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Company Offers Public Use of 3D Printers

December 16, 2013 1:40 pm | by Amy Hamilton, The Daily Sentinel | Comments

In a workshop at Grand Junction's Business Incubator Center, employees with Apex CAD Products use three-dimensional printers to make an array of items for customers, from models of dental implants and vertebrae for medical professionals to ...

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Henry Ford Hospital Implants New Defibrillator for People at Risk of Sudden Cardiac Arrest

December 16, 2013 1:12 pm | by PR Newswire | Comments

A new internal defibrillator, on the cusp of a new standard of care in American cardiology to treat patients for a major heart risk, is being used at Henry Ford Hospital. Compared to the current devices used to treat sudden cardiac arrest...

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