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The Lead

Hybrid 'Patch' Could Replace Transplants

October 1, 2014 11:00 am | by American Friends of Tel Aviv University | News | Comments

Because heart cells cannot multiply and cardiac muscles contain few stem cells, heart tissue is unable to repair itself after a heart attack. Now Tel Aviv University researchers are literally setting a new gold standard in cardiac tissue...

The FDA Takes Steps to Strengthen Cybersecurity of Medical Devices

October 1, 2014 10:29 am | by FDA | News | Comments

To strengthen the safety of medical devices, the U.S. Food and Drug Administration today...

CE Mark for LoneStar Heart’s Hydrogel Implant for the Treatment of Advanced Heart Failure

October 1, 2014 10:25 am | by PR Newswire | News | Comments

LoneStar Heart, Inc. has announced that it received the CE Mark for its Algisyl-LVR hydrogel...

Tissue Valves as Safe as Mechanical Valves in Middle-Aged Patients

October 1, 2014 9:39 am | by Mount Sinai Health System | News | Comments

New Icahn School of Medicine at Mount Sinai research findings published in the October 1 issue...

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Homeland Security and FDA Address Medical Device Cybersecurity

September 30, 2014 11:53 am | by AAMI | News | Comments

The Department of Homeland Security is joining forces with the U.S. Food and Drug Administration (FDA) to tackle the issue of medical device cybersecurity—a tacit recognition of the emerging vulnerabilities associated with healthcare technology...

AliveCor Launches New App to Auto Detect Atrial Fibrillation in an ECG Recording

September 30, 2014 9:53 am | by AliveCor | News | Comments

AliveCor, Inc. announced today the launch of the latest version of the AliveECG app, which provides patients with free real-time atrial fibrillation (AF) detection in ECG recordings using its new FDA-cleared algorithm. The new app helps...

CE Mark for CVRx's Barostim neo System for the Treatment of Heart Failure

September 29, 2014 10:28 am | by PR Newswire | News | Comments

CVRx, Inc., a private medical device company, announced today it received CE Mark approval from the National Standards Authority of Ireland (NSAI) of the Barostim neo System for the treatment of heart failure.  The therapy is approved for use...

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CE Mark for ReFlow Medical’s Wingman35 Crossing Catheter and SpeX Shapeable Support Catheter

September 26, 2014 4:00 pm | by Business Wire | News | Comments

ReFlow Medical, Inc. (ReFlow) has announced the initial clinical use of their Wingman35 Crossing Catheter and speX Shapeable Support Catheter by Dr. Andrej Schmidt at University Leipzig, Germany. The devices were recently granted European...

Heart Hospital of Austin First in Texas To Offer New Heart Failure Monitoring System

September 26, 2014 3:46 pm | by PR Newswire | News | Comments

On Sept. 24, 2014, Heart Hospital of Austin became the first facility in Texas to implant a new miniaturized, wireless monitoring sensor to manage heart failure (HF). The CardioMEMS HF System is the first and only FDA-approved heart failure...

Photos of the Day: Color-Changing Heart and Skin Monitoring Patch

September 25, 2014 2:38 pm | by Megan Fellman, Northwestern University | News | Comments

The small device, approximately five centimeters square, can be placed directly on the skin and worn 24/7 for around-the-clock health monitoring. The wireless technology uses thousands of tiny liquid crystals on a flexible substrate to sense...

‘Skin-Like’ Device Monitors Cardiovascular and Skin Health

September 25, 2014 11:05 am | by Megan Fellman, Northwestern University | News | Comments

A new wearable medical device can quickly alert a person if they are having cardiovascular trouble or if it’s simply time to put on some skin moisturizer, reports a Northwestern University and University of Illinois at Urbana-Champaign study...

September 2014 Digital Edition

September 24, 2014 4:57 pm | by MDT Staff | Digital Editions | Comments

Designers developing medical devices that are introduced into the body through a catheter or similar solution have very specific characteristics that need to be achieved for that transfer system. Streamlined Process for Wire-Reinforced Catheters and...

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Skin Cells Can Be Engineered into Pulmonary Valves for Pediatric Patients

September 24, 2014 11:38 am | by Elsevier | News | Comments

Researchers have found a way to take a pediatric patient's skin cells, reprogram the skin cells to function as heart valvular cells, and then use the cells as part of a tissue-engineered pulmonary valve. A proof of concept study published in...

Boston Scientific Enrolls First Patients In U.S. Trial Of The Lotus Valve System

September 24, 2014 10:42 am | by PR Newswire | News | Comments

Boston Scientific Corporation has initiated the REPRISE III clinical trial, a pivotal study to evaluate the safety and effectiveness of the Lotus Valve System in patients with severe aortic stenosis and who are considered to be at either high...

NOVAPLUS Contract for Disposable Blood Pressure Cuffs Awarded to Welch Allyn

September 24, 2014 10:06 am | by PR Newswire | News | Comments

Welch Allyn, Inc., a leading medical diagnostic device company that delivers pragmatic innovation at the point of care, and Novation, a leadinghealth care services company, today announced a new three-year contract for disposable blood pressure...

Designing a Heart Rate Monitor for Wearable Devices

September 24, 2014 8:30 am | by Anand Udupa, Praveen Aroul, Texas Instruments | Texas Instruments Inc. | Articles | Comments

Within a few years about 170 million wireless devices are expected to be able to track personal health. Optical heart rate monitoring (OHRM) on an intelligent platform like a smartwatch or a smartphone provides the capability to continuously...

Nanotubes Help Healing Hearts Keep the Beat

September 23, 2014 11:41 am | by Rice University | News | Comments

Carbon nanotubes serve as bridges that allow electrical signals to pass unhindered through new pediatric heart-defect patches invented at Rice University and Texas Children's Hospital. A team led by bioengineer Jeffrey Jacot and chemical engineer...

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House Supports Repeal of Medical Device Tax

September 23, 2014 11:22 am | by AAMI | News | Comments

The U.S. House of Representatives has passed a bill that includes a repeal of the 2.3% medical device, but the measure faces an uphill battle in the Senate, and previous roll-back efforts have fallen short. HR 4, the “Jobs for America Act,”...

First Test to Identify Five Yeast Pathogens Directly from a Blood Sample

September 23, 2014 9:30 am | by U.S. Food and Drug Administration | News | Comments

The U.S. Food and Drug Administration today allowed marketing in the U.S. of the first direct blood test for detection of five yeast pathogens that cause bloodstream infections: Candida albicans and/or Candida tropicalis, Candida parapsilosis...

Variability Keeps the Body in Balance

September 22, 2014 3:38 pm | by California Institute of Technology | News | Comments

Although the heart beats out a very familiar "lub-dub" pattern that speeds up or slows down as our activity increases or decreases, the pattern itself isn't as regular as you might think. In fact, the amount of time between heartbeats can...

One-Year Outcomes Are Good for Patients Treated with Superficial Femoral Artery Stent

September 22, 2014 10:52 am | by Journal of Endovascular Therapy | News | Comments

The use of stents has improved management and outcomes of coronary artery disease, and clinical trials are attempting to prove the same will be true for superficial femoral artery disease. Randomized trials have shown favorable results for self...

CE Mark and European Launch of Medtronic’s TYRX Absorbable Antibacterial Envelope

September 22, 2014 10:33 am | by Medtronic | News | Comments

Medtronic, Inc. has received CE (Conformité Européenne) Mark for the TYRX Absorbable Antibacterial Envelope. This innovative mesh envelope covers an implantable cardiac device to help stabilize the device after implantation and reduce surgical...

CE Mark Grants St. Jude’s Pacing Lead Expanded Patient Access to MRI Scans

September 22, 2014 9:31 am | by The Associated Press | News | Comments

St. Jude Medical, Inc., a global medical device company, has announced CE Mark approval of updated labeling for its Tendril STS and IsoFlex Optim pacing leads, allowing existing and future patients with the devices access to magnetic resonance...

FDA Approves Gore's VIABAHN Endoprosthesis for Endovascular Treatment of In-Stent Restenosis

September 22, 2014 9:22 am | by The Associated Press | News | Comments

W. L. Gore & Associates, Inc. (Gore) today announced that the Food and Drug Administration (FDA) has approved the GORE VIABAHN Endoprosthesis for interventional treatment of in-stent restenosis in the superficial femoral artery (SFA). Now...

Solution for Precision-Sensing in Portable Medical Devices

September 22, 2014 8:30 am | by MDT Staff | Product Releases | Comments

ON Semiconductor has responded to rapidly-evolving product development demands within the portable medical market by introducing Struix, a semi-customizable System-in-Package (SiP) solution for precision sensing and monitoring in a variety of mobile medical electronics...

First-in-Man Procedure Utilizes a New Method of Stem Cell Delivery

September 19, 2014 3:50 pm | by PR WEB | News | Comments

The Translational Research Institute “TRI Medical” announced today that its new ND Infusion Catheter is being used in a first-in-man procedure at the University of Frankfurt. The study commenced on September 4th, 2014 at the University of...

The Pulse: Yawning at the Apple Watch and Diagnosing on the Go

September 18, 2014 10:23 am | by Jonathan Dipierro, Multimedia Production Specialist | Videos | Comments

On this episode of the Pulse, we’re yawning at the Apple Watch, testing blood, urine or saliva in minutes, determining cancer treatment with a 3D printed heart, and tracking fitness with our feet. Apple Watch: Last week came the much...

Stanford Researcher Leads International Trial to Compare Heart-Disease Treatments

September 18, 2014 10:04 am | by Tracie White, Science Writer, Stanford University School of Medicine | News | Comments

Researchers have announced the enrollment of the first patient in an international, multicenter clinical trial comparing the effectiveness of two different treatments for multivessel coronary artery disease. Coronary artery disease is the...

Accelerated Heart Valve Durability Testing

September 17, 2014 8:30 am | by MDT Staff | Bose Corp. | Product Releases | Comments

Bose Corporation has introduced DuraPulse, a new instrument for accelerated durability testing of heart valve replacement devices. Featuring proprietary Bose controls and linear motor technology, the DuraPulse system enables research and development engineers to run tests at high frequencies...

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