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Life-Saving, Smart Regulation on Behalf of Patients with Aortic Stenosis

June 17, 2014 9:50 am | by Jeffrey Shuren, M.D., Director – Center for Devices and Radiological Health, FDA | Blogs | Comments

At FDA’s medical devices center, we have a vision — it’s what we strive for each day in our review and assessment of new medical technology. And patients are at the very core of that vision: “Patients in the U.S. have access to high-quality...

Regenerating Our Kidneys

June 17, 2014 9:38 am | by American Friends of Tel Aviv University | News | Comments

Doctors and scientists have for years been astonished to observe patients with kidney disease experiencing renal regeneration. The kidney, unlike its neighbor the liver, was universally understood to be a static organ once it had fully...

Engineer to Grow Replacement Tissue for Torn Rotator Cuffs

June 17, 2014 9:15 am | by Case Western Reserve University | News | Comments

A Case Western Reserve University engineer has won a $1.7 million National Institutes of Health (NIH) grant to grow replacement rotator cuffs and other large tendon groups to help heal injured soldiers and athletes, accident victims and an...

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Research Set to Improve Quality of Life for Denture Patients

June 17, 2014 9:09 am | by Manchester University | News | Comments

Manchester Academic Health Science Centre (MAHSC) is managing a trial into the quality of life of people wearing dental implants. The trial is funded by the National Institute of Health Research (NIHR) Research for Patient Benefit Programme...

Edwards Lifesciences Launching SAPIEN XT Valve in the U.S.

June 16, 2014 6:29 pm | by PR Newswire | News | Comments

Edwards Lifesciences Corporation, the global leader in the science of heart valves and hemodynamic monitoring, has announced that it has received United States Food and Drug Administration (FDA) approval for its Edwards SAPIEN XT...   

Sensor in Eye Could Track Pressure Changes, Monitor for Glaucoma

June 16, 2014 3:20 pm | by Michelle Ma, University of Washington | News | Comments

Your eye could someday house its own high-tech information center, tracking important changes and letting you know when it’s time to see an eye doctor. University of Washington engineers have designed a low-power sensor that could be placed...

PowerVision Secures $30 Million in Funding for Implantable Lens

June 16, 2014 2:27 pm | by PR Newswire | News | Comments

PowerVision, Inc., a medical device company developing the world's first fluid-based accommodating intraocular lens, today announced that the company has completed a $30 million Series D financing round. New investors Aisling Capital and...

How to Market Your Device

June 16, 2014 9:34 am | by U.S. Food & Drug Administration | News | Comments

Medical devices marketed in the United States are subject to the regulatory controls in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the regulations in Title 21- Code of Federal Regulations (21 CFR) Parts 1-58, 800-1299... 

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Medtronic to Buy Covidien

June 16, 2014 9:10 am | by Josh Boak, AP Business Writer | News | Comments

U.S. medical device manufacturer Medtronic has agreed to buy Ireland-based competitor Covidien for $42.9 billion in cash and stock. The combined company would have its executive offices in Dublin, where it could benefit from Ireland's lower...

Spectrum Health Among First to Implant Neurostimulator for Epilepsy

June 13, 2014 11:45 am | by Spectrum Health | News | Comments

Spectrum Health is the first health system in Michigan and among the first in the nation to successfully implant a recently FDA-approved device that uses electric stimulation of the brain to treat adult epilepsy patients whose seizures have...

Lab Awarded $5.6 Million to Develop Next-Generation Neural Devices

June 13, 2014 11:38 am | by DOE/Lawrence Livermore National Laboratory | News | Comments

Lawrence Livermore National Laboratory recently received $5.6 million from the Department of Defense's Defense Advanced Research Projects Agency (DARPA) to develop an implantable neural interface with the ability to record and stimulate...

Medtronic Heart Valve Approved for Broader Use

June 13, 2014 11:14 am | by The Associated Press | News | Comments

Medtronic Inc. said Thursday that the FDA approved its artificial heart valve, CoreValve, for use in more patients who face serious risks from open-heart surgery, the standard treatment. Medtronic's implant is a less invasive approach to...

ulrich medical Releases New Spinal Implant for U.S. Market

June 12, 2014 5:29 pm | by The Associated Press | News | Comments

ulrich medical USA, Inc., has announced the U.S. market release of the uCentum Comprehensive Posterior System for open and minimally invasive (MIS) surgical approaches which is intended to provide immobilization and stabilization of spinal...

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Implanted Infection Prevention

June 12, 2014 12:44 pm | by Fraunhofer | News | Comments

Hospital germs can be fatal, since they are resistant to antibiotics. As a result, alternative methods of defense against bacteria are in demand. Fortunately, a German-French research team has been able to develop bone implants that keep the germs at bay. The figures are alarming ...

Stem Cells Are a Soft Touch for Nano-Engineered Biomaterials

June 10, 2014 4:11 pm | by Neha Okhandiar, Queen Mary University of London | News | Comments

Scientists from Queen Mary University of London have shown that stem cell behaviour can be modified by manipulating the nanoscale properties of the material they are grown on - improving the potential of regenerative medicine and tissue engineering as a result. Stem cells ...

First Patient Receives HeartAssist5 VAD Following CE Mark Approval

June 9, 2014 5:23 pm | by ReliantHeart | News | Comments

Privately-held ReliantHeart, a leading innovator in mechanical circulatory support therapies, announced the first advanced stage heart failure patient received its next generation HeartAssist5 Ventricular Assist Device (VAD) since the company...

Surgeon Performs World’s First Spinal Fusion Surgery Using Customized 3-D Printed Spine Cages

June 9, 2014 7:26 am | by The Associated Press | News | Comments

The group, a company that specializes in the development of innovative surgical technologies for the treatment of complex spinal pathologies, announced that a surgeon in Lyon, France has performed the world’s first spinal fusion surgery using...

Better Tissue Healing with Disappearing Hydrogels

June 6, 2014 2:50 pm | by University of Rochester | News | Comments

When stem cells are used to regenerate bone tissue, many wind up migrating away from the repair site, which disrupts the healing process. But a technique employed by a University of Rochester research team keeps the stem cells in place... 

CardiAQ Valve Technologies Files Lawsuit Against Neovasc

June 6, 2014 1:31 pm | by The Associated Press | News | Comments

CardiAQ Valve Technologies, a leader in the field of Transcatheter Mitral Valve Implantation, announced today that it has filed a federal lawsuit in Boston, Mass. against Neovasc, Inc. for fraud, misappropriation of trade secrets, breach of...

Medical Technology Highlights of 2014 Symposia on VLSI Technology & Circuits

June 5, 2014 4:01 pm | by Jeffrey Gealow, Circuits Program Chair, 2014 Symposia on VLSI Technology & Circuits | Blogs | Comments

The integration of more advanced electronics technology into medical devices for patient monitoring, diagnosis and treatment continues at an ever-increasing rate, with new developments being announced daily. Among these significant technology...

Implanted Heart Device Linked to Increased Survival

June 4, 2014 3:45 pm | by Duke Medicine | News | Comments

Implantable cardioverter defibrillators (ICDs) are associated with improved survival among heart failure patients whose left ventricles only pump 30 to 35 percent of blood out of the heart with each contraction, according to a study from the...

The Pulse: Sperm-Inspired Microbots and Seinfeld’s ‘Bro’

June 4, 2014 12:21 pm | by Jonathan Dipierro, Multimedia Production Specialist | Videos | Comments

This week on the Pulse, we’re checking out Apple’s Health and Healthkit, developing sperm-inspired microrobots for biomedical applications, wearing the Bro (Manssiere), and growing cartilage from stem cells derived from fat tissue.  

AxoGen Receives DoD Funding for Next Generation Peripheral Nerve Repair Research

June 4, 2014 10:35 am | by AxoGen | News | Comments

AxoGen Inc., the emerging leader of the $1.6 billion U.S. peripheral nerve repair market, announced that it would share in the award of two Department of Defense Grants totaling approximately $1.9 million with Brigham and Women’s Hospital...

Arthrosurface Implants the First ToeMotion Total Toe in the U.S.

June 4, 2014 9:59 am | by PR Newswire | News | Comments

Arthrosurface, Inc., a developer of less-invasive joint restoration systems, performed its first ToeMotion total toe surgeries with Dr. Carl Hasselman last week at UPMC in Pittsburgh, PA. Dr. Hasselman, who has been using the HemiCAP system...

Implantable Extraocular Sensor Measures Intraocular Pressure in Glaucoma Patients

June 3, 2014 10:42 am | by Implandata Ophthalmic Products GmbH | News | Comments

Implandata Ophthalmic Products GmbH and Professor Peter Szurman, Head of “Section Experimental Ophthalmic Surgery” at Eye Hospital of University Tübingen, have started pre-clinical studies for the first implantable, permanent extraocular...

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