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CytoVas And BD Biosciences Ink Alliance To Co-Develop Personalized Diagnostic For Vascular Health

April 25, 2013 3:52 pm | by Bio-Medicine.Org | News | Comments

PHILADELPHIA , April 25, 2013 /PRNewswire-iReach/ -- CytoVas, LLC and BD Biosciences, a division of BD (Becton,  Dickinson and Company), announced today they have formed a strategic alliance to jointly develop a new blood-based diagnostic test to predict individualized patient risk of heart attack and stroke.  This test, currently called the Vascular Health Profile (VHP), fills a...

April 2013 Digital Edition

April 25, 2013 2:45 pm | by MDT Staff | Digital Editions | Comments

Given the number of device applications that involve the transfer of a gas or liquid, it is no wonder pump technology is such a significant part of many healthcare-related products. “Innovation Drives Pump Technology to Meet Today’s Medical Designs” focuses on how today’s medical device demands are being answered by advanced pump technology.

Potential for Delivery System Catheter Separation Prompts Cook Medical To Initiate Voluntary Global Recall of Zilver® PTX® Drug Eluting Stent

April 24, 2013 4:40 pm | by The Associated Press | News | Comments

Based on its investigation into a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter, Cook Medical has initiated a nationwide/global voluntary recall of its Zilver® PTX® Drug Eluting Peripheral Stent.

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Vascular Solutions can't dodge illegal marketing lawsuit

April 24, 2013 3:11 pm | by Mass Device | News | Comments

Minnesota medical device maker Vascular Solutions (NSDQ:VASC) wasn't able to dodge a federal off-label marketing lawsuit over its Vari-Lase varicose vein treatment devices, the company revealed in its latest financial report. A Texas court ruled last month against Vascular Solutions' motion to dismiss a U.S. Attorney's Office complaint...

Is a Hacked Pacemaker Capable of Mass Murder?

April 24, 2013 10:23 am | by Kasey Panetta, Managing Editor, ECN | Blogs | Comments

When you are a patient in a hospital, you tend to expect that the electronics are either top of the line or at least functioning correctly. You expect that the devices doctors implant in your body are reliable and safe. These seem like safe assumptions. Unfortunately, you could be mistaken.

Millstone Medical Outsourcing Expands Medical Device Distribution Services

April 23, 2013 6:05 pm | by PR Newswire | News | Comments

Millstone Medical Outsourcing announced today that the company will offer customers an expanded medical device distribution service, which includes the ability to distribute directly to patients and to provide wholesale distribution to distributors, hospitals, and sales representatives.

Stanford Researchers Develop New Method to Assess Options for Heart-Disease Surgery

April 23, 2013 10:36 am | by Stanford University Medical Center | News | Comments

Researchers at the Stanford University School of Medicine have developed a method of predicting which patients with heart disease would benefit more from surgery and which would benefit more from angioplasty. Drawing on Medicare records of more than 100,000 patients with heart disease, the team demonstrated that the effectiveness of coronary bypass surgery varied widely based on each individual's characteristics.

Drug Reduces Fat by Blocking Blood Vessels

April 23, 2013 10:20 am | by American Physiological Society | News | Comments

Researchers have long known that cancerous tumors grow collections of abnormal blood cells, the fuel that feeds this disease and keeps it growing. Now, new evidence in an animal model suggests that blood vessels in the fat tissue of obese individuals could provide the same purpose—and could provide the key to a new way for people to lose weight.

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3v07 Medical Advertising Introduces Social Anthropology Product

April 23, 2013 9:17 am | by The Associated Press | News | Comments

LAGUNA BEACH, Calif.--(BUSINESS WIRE)--Apr 23, 2013--Healthcare advertising is seeing more medical device companies going direct to consumers thanks to the effectiveness of the Internet in reaching people looking for answers online to their medical conditions. This has made it important for...

InspireMD Receives Approval From US Food and Drug Administration to Begin US Regulatory Trial

April 23, 2013 8:43 am | by The Associated Press | News | Comments

InspireMD, Inc. (NYSE MKT: NSPR) ("Inspire" or the "Company"), the developer of the MGuardT Embolic Protection Stent (EPS), announced today that on April 19, 2013, the Company received an approval with conditions for its Investigational Device Exemption (IDE) application with the U.S. Food...

Meeting the FDA’s Mandates for Unique Device Identification

April 22, 2013 2:22 pm | by Hiroshi Ono, Group Product Manager, Roland DGA Corp. | Roland DGA Corporation | Articles | Comments

The FDA’s UDI rule is on its way and will impact virtually everyone in the industry in one way or another. While the rule has its benefits, getting to compliance will not be achieved overnight. This article provides an overview of the direct part marking technologies required to comply with the UDI rule and offers a solution that addresses the shortcomings of several other technologies.

The Malware Threat

April 22, 2013 2:06 pm | by Sean Fenske, Editor-in-Chief, MDT | Blogs | Comments

When my mother tells me that her computer is running slow and she needs me to “clean it up” for her, I never imagined the day she might be calling about the same problem with a medical device. While I’d obviously not have the same access to it that I have on a computer, it does reflect a scary situation in medical device technology today.

PDL BioPharma Completes Structured Financing and Royalty Transaction with Avinger

April 22, 2013 12:50 pm | by PR Newswire | News | Comments

INCLINE VILLAGE, Nev., April 22, 2013 /PRNewswire/ -- PDL BioPharma, Inc. (PDL) (NASDAQ: PDLI) and Avinger, Inc. announced today that they closed a structured financing and royalty transaction on April 18, 2013, in which PDL will provide Avinger with up to $40 million of...

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Electrophysiology Devices Market Worth US$4.4 billion by 2015

April 22, 2013 12:36 pm | by PR Newswire | News | Comments

DALLAS, April 22, 2013 /PRNewswire-iReach/ -- "Global Electrophysiology (EP) Devices- Market Growth Analysis, 2009-2015" and "Electrophysiology (EP) Devices – Emerging Markets (Brazil, Russia, India, China, South Africa And South Korea), 2009-2015" are new reports available at RnR...

TriReme Receives Shonin Approval to Market Glider™ PTCA Catheter

April 22, 2013 9:01 am | by PR Newswire | News | Comments

PLEASANTON Calif. and SINGAPORE, April 22, 2013 /PRNewswire/ -- TriReme Medical, Inc. and its affiliates (TriReme) announced today that its Japanese partner, Century Medical, Inc. (CMI), has received Shonin approval for the Glider™ PTCA catheter indicated for treating the...

Healthcare's First Direct Contracting Market Launches Today; Will Offer Mutually Beneficial Approach for Hospitals and Suppliers

April 22, 2013 9:00 am | by PR Newswire | News | Comments

IRVING, Texas, April 22, 2013 /PRNewswire/ -- Today aptitude announced the launch of the healthcare industry's first online direct contracting market, a one-stop destination designed to complement a hospital's existing contracting model or provide an alternative for those looking...

ARCA biopharma and Medtronic to Collaborate on Atrial Fibrillation Clinical Trial for Gencaro

April 22, 2013 8:00 am | by The Associated Press | News | Comments

BROOMFIELD, Colo.--(BUSINESS WIRE)--Apr 22, 2013--ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that it has entered into an agreement with Medtronic, Inc. (NYSE:MDT), a leader in medical...

ZOLL and Reflectance Medical Form Development Agreement to Incorporate Mobile CareGuide Sensor into ZOLL Monitor/Defibrillators

April 18, 2013 10:18 am | by The Associated Press | News | Comments

CHELMSFORD, Mass.--(BUSINESS WIRE)--Apr 18, 2013--ZOLL Medical Corporation, a manufacturer of resuscitation devices and related software solutions, announced today that it has entered into an agreement with Reflectance Medical, Inc. of Westborough, Mass., to develop and market a ruggedized...

Hand-Held Device Provides Lab-Quality Troponin Test Results in 15 Minutes to Identify Patients Suspected of Heart Attack

April 18, 2013 8:31 am | by The Associated Press | News | Comments

Silicon BioDevices, based in Berkeley, Calif., today presented the results of a pivotal benchmark study of its digital handheld device for high-sensitivity measurement of cardiac troponin-I, a protein found in the heart muscle used to identify heart tissue damage in patients suspected of having a heart attack.

Vasomedical Introduces Policy Makers Focusing on Healthcare Reform to EECP@ Therapy

April 16, 2013 8:30 am | by The Associated Press | News | Comments

Currently, the United States spends more on healthcare services than any other country, exceeding $2.6 trillion, or about 18 percent of gross domestic product, annually. Most years, medical spending rises faster than inflation and the economy as a whole, which makes this a top priority for...

American College of Cardiology Journal Publishes Outcomes of Diabetes Patients Treated with Medtronic's Resolute Stent

April 15, 2013 9:06 am | by The Associated Press | News | Comments

The current issue of JACC: Cardiovascular Interventions, a peer-reviewed journal published by the American College of Cardiology, includes an article that describes how the Resolute Integrity drug-eluting stent from Medtronic became the first and only device of its kind to be approved by the FDA with a specific indication for treating the coronary artery disease of patients with diabetes mellitus.

Randomized Controlled Multi-Center Trial Demonstrates Reduced Treatment Time and Drug Dose with EKOS vs. Catheter-Directed Thrombolysis in Peripheral Arterial Occlusions

April 15, 2013 9:00 am | by The Associated Press | News | Comments

BOTHELL, Wash.--(BUSINESS WIRE)--Apr 15, 2013--EKOS Corporation, a privately held medical device company located in Bothell, Washington, announced the results of DUET, the world’s first and only multi-center randomized trial that compares ultrasound-accelerated, catheter-directed thrombolysis...

Stenting Blocked Bowel Arteries Saves Lives

April 14, 2013 10:00 am | by PR Newswire | News | Comments

Stenting reopens completely blocked bowel arteries, preventing damage and even death from a condition that causes individuals severe pain and leads to excessive weight loss, notes research being presented at the Society of Interventional Radiology's 38th Annual Scientific Meeting in New Orleans, La.

St. Jude-backed iRhythm Technologies raises another $16M for Zio wearable heart monitor

April 12, 2013 10:48 am | by Mass Device | News | Comments

iRhythm Technologies said it closed a $16 million Series D round for its Zio wearable heart monitor, saying it plans to use the proceeds to further its commercial footprint and research & development efforts. Led by Norwest Venture Partners, which added partner Casper de Clercq to iRhythm's board, the latest financing including contributions from existing backers...

Franciscan St. Francis Health Is First Hospital in Nation to Implant Breakthrough Aortic Heart Valve Device

April 11, 2013 2:30 pm | by PR Newswire | News | Comments

INDIANAPOLIS, April 11, 2013 /PRNewswire-USNewswire/ -- Franciscan St. Francis Health is the first hospital in the United States to implant a new device that could improve the quality of life for patients with aortic valve disease. The On-X® Aortic Prosthetic Valve with...

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