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6 Considerations When Implementing Agile in Medical Device Development

March 23, 2015 10:18 am | by Heidi Giesbrecht, MEng, Project Manager, StarFish Medical | Blogs | Comments

The benefits of Agile include improved quality, more opportunities for midcourse corrections, improved customer or business satisfaction, better alignment between business and IT and improved time to market,” according to a Forrester Research...

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Blood Test for Patients on Acne Medication Deemed Unnecessary

March 23, 2015 9:49 am | by Brigham and Women's Hospital | News | Comments

A new study by researchers at Brigham and Women's Hospital (BWH) has found that for young, healthy women taking spironolactone to treat hormonal acne, frequent office visits and blood draws are an unnecessary health care expense. For the...

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Medical Device Tax Repeal Included in Senate Republican Budget

March 23, 2015 9:42 am | by The United States Senate Committee on Finance | News | Comments

Finance Committee Chairman Orrin Hatch (R-Utah) and U.S. Senator Pat Toomey, (R-Pa.), a member of the Committee, praised the inclusion of the medical device tax repeal in the Senate Republican budget. Under Patient Protection and Affordable...

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FDA Approves MRI-Safe Pacemaker

March 23, 2015 9:37 am | by The Associated Press | News | Comments

BIOTRONIK, a manufacturer of cardiovascular medical devices, announced today that the Food and Drug Administration (FDA) has approved its ProMRI Eluna pacemaker system. BIOTRONIK ProMRI technology allows patients to undergo full-body magnetic...

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Stem Cells Show Promise for Reversing Type 2 Diabetes

March 23, 2015 9:33 am | by University of British Columbia | News | Comments

Scientists at the University of British Columbia and BetaLogics, part of Janssen Research & Development, LLC have shown for the first time that Type 2 diabetes can be effectively treated with a combination of specially-cultured stem cells...

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Choosing IV Devices Carefully

March 23, 2015 9:25 am | by University of Michigan Health System | News | Comments

Every day, patients around the country get IV devices placed in their arms, to make it easier to receive medicines or have blood drawn over the course of days or weeks. But these PICC lines, as they're called, also raise the risk of potentially...

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The Future of Cardiology Is in Personalized Parts

March 23, 2015 9:20 am | by Henry Ford Health System | News | Comments

Experts in advanced cardiology believe custom-fitting patients with personalized heart valves is a few short years away. Henry Ford Hospital cardiologist Dee Dee Wang, M.D.; mentor and renowned cardiologist William O’Neill, M.D., and experts...

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FDA Hosting Public Workshop On Device Risk in Postmarket Setting

March 23, 2015 8:38 am | by AAMI | News | Comments

The U.S. Food and Drug Administration (FDA) is hosting a public workshop next month on the clinical considerations of risk with a medical device that is already on the market and in use. The agency says it wants to hear from all stakeholders...

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CT Scans Appear to Dramatically Improve Diagnosis of Heart Disease

March 22, 2015 10:20 am | by American College of Cardiology | News | Comments

Use of computed tomography coronary angiography, which provides 3-D images of the heart, coupled with standard care allows doctors to more accurately diagnose coronary artery disease in patients presenting with chest pain, therefore, leading...

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Self-Expanding TAVR Widens Advantage over Surgery at Two Years

March 22, 2015 8:27 am | by American College of Cardiology | News | Comments

Two-year data show a continued survival advantage for self-expanding transcatheter aortic valve replacement (TAVR) over standard surgery in high-risk patients with severe aortic stenosis, according to research presented at the American College of...

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SAPIEN 3 Improves 30-Day Outcomes for Major Endpoints

March 21, 2015 10:23 am | by American College of Cardiology | News | Comments

The SAPIEN 3 heart valve demonstrated lower death, stroke and paravalvular leak rates than earlier generation devices in patients at high risk for surgery and showed encouraging results in intermediate-risk patients, according to research presented...

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Benefits Seen for First-in-Field Brain Shield Used with TAVR

March 21, 2015 9:11 am | by American College of Cardiology | News | Comments

An investigational device that deflects debris away from the brain during transcatheter aortic valve replacement seems to improve in-hospital safety outcomes and cognitive scores at discharge, according to preliminary findings from a small...

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Sandia Showcases Biology Breakthroughs

March 20, 2015 3:50 pm | by DOE/Sandia National Laboratories | News | Comments

Technologies developed in Sandia National Laboratories' biosciences program could soon find their way into doctors' offices -- devices like wearable microneedles that continuously analyze electrolyte levels and a lab-on-a-disk that can test a...

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Mechanically Stimulating Stem Cells

March 20, 2015 3:41 pm | by Denis Paiste, Materials Processing Center, MIT | News | Comments

Researchers in MIT Associate Professor Krystyn J. Van Vliet's group last year showed that three biomechanical and biophysical markers could accurately identify the most desirable stem cells from a mixed group of bone marrow-derived cells...

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3 Ways Athletic MedTech Is Changing the Game

March 20, 2015 3:25 pm | by Sam Brusco, Associate Editor, @SamISureAm | Blogs | Comments

It pretty much goes without saying – if you’re an athlete, at some point you’re going to get hurt. (Golfers and professional curling players notwithstanding.) Whether it’s a baseball to the head, a particularly nasty football tackle, or an ill-timed kick to the groin...

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