Medical Devices News and Research

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CardioKinetix reports meta-analysis study results of Parachute Ventricular Partitioning Device

CardioKinetix Inc., a medical device company pioneering a catheter-based treatment for heart failure, today announced results of a meta-analysis study of the first-of-its-kind catheter-based Parachute Ventricular Partitioning Device. Six-month clinical results from 91 U.S. and European patients with ischemic heart failure were presented at the 2013 EuroPCR Conference in Paris by Dr. Martyn Thomas, M.D., chairman of Cardiology at St. Thomas Hospital in London, England.

23 May 2013

Viewpoints: Mass. experience may not be true test for national health law; 'Dishonest' campaign by medical device makers

Massachusetts is often held up as a window into America's health insurance future, because it embarked on what came to be called the Romneycare reform six years ago. Like the Affordable Care Act provisions going into effect nationwide next year, Romneycare aimed to increase the fraction of the population with health insurance by imposing mandates on employers and employees and by subsidizing health insurance plans for middle-class families without employer plans.

23 May 2013

Safety and efficacy evaluation methods for medical devices

Medical devices are any medical items that are neither a drug nor a biological product. In light of their different mechanisms, actions and regulatory requirements, medical device trail evaluations are much more complicated than drug trails due to their unique clinical practices.

18 May 2013

Clinical data on Cook Medical products to be presented at Digestive Disease Week®

At this week’s Digestive Disease Week (DDW), the world’s largest gathering of physicians and researchers in the gastroenterology field, six abstracts and other clinical data will be presented on Cook Medical products. Cook’s EchoTip® ProCore™ High Definition Ultrasound Biopsy needles are featured in many of these presentations.

17 May 2013

GfK to deliver major presentation on personalized medicine at PBIRG Annual General Meeting

GfK will deliver a major presentation about patient perspectives' on personalized medicine at the Pharmaceutical Business and Intelligence Research Group Annual General Meeting, taking place May 19 to 22 in Naples, Florida.

17 May 2013

Ambulatory syringe pump training: an interview with Ruth Goodwin RGN, BSc Clinical Education Manager for CME Medical

Ambulatory pumps allow patients to continue receiving treatment or therapy away from a hospital, thereby leading a normal life during treatment. Due to the size and design of these pumps, patients can carry them around in a carry pouch.

17 May 2013

Elixir's DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System receives CE Mark approval

Elixir Medical Corporation, a developer of product platforms that combine state-of-the-art medical devices with advanced pharmaceuticals, announced that it has received CE (Conformité Européenne) Mark approval for its DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System.

15 May 2013

Search, Share, Spare campaign to raise awareness about breast cancer surgery options

Studies have shown nearly 70 percent of patients with breast cancer do not discuss all surgical options with their surgeon before their initial surgery and that such a discussion significantly affects a woman's treatment decision.

15 May 2013

Polymer substance fully resists the body's natural attack response to foreign objects

It's a familiar scenario - a patient receives a medical implant and days later, the body attacks the artificial valve or device, causing complications to an already compromised system.

15 May 2013

TriStar Wellness Solutions completes acquisition of HemCon Medical Technologies

TriStar Wellness Solutions, Inc., a health and wellness company that targets opportunities in the self-care and professional marketplace, has acquired HemCon Medical Technologies Inc., a Portland, Oregon-based leading researcher and manufacturer of products for bleeding and wound management.

13 May 2013

HTSI to receive GE Healthcare-AACN Pioneering Spirit Award

The Healthcare Technology Safety Institute (HTSI) — a program of the Association for the Advancement of Medical Instrumentation Foundation, Arlington, Va. — will receive the GE Healthcare-AACN Pioneering Spirit Award.

10 May 2013

Uroplasty highlights results of STEP Study on PTNS treatments for overactive bladder

Uroplasty, Inc., a medical device company that develops, manufactures and markets innovative proprietary products for the treatment of voiding dysfunctions, today highlighted the 3-year results of the STEP Study on percutaneous tibial nerve stimulation treatments for overactive bladder using Uroplasty's Urgent PC Neuromodulation System.

10 May 2013

Echo Therapeutics reports net loss of $7.0 million for first quarter 2013

Echo Therapeutics, Inc., a company developing its needle-free Symphony CGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system, today announced financial results for the quarter ended March 31, 2013.

10 May 2013

Scientists use phages to prevent bacteria on medical devices

They're ba-ack! But in a new disease-fighting role. Viruses that infect and kill bacteria - used to treat infections in the pre-antibiotic era a century ago and in the former Soviet Union today - may have a new role in preventing formation of the sticky "biofilms" of bacteria responsible for infections on implanted medical devices.

9 May 2013

Federal judge criticizes FDA regarding Plan B contraception decision

Judge Edward R. Korman said the Food and Drug Administration's efforts to delay his ruling regarding the so-called morning-after pill was "nonsense" and would hurt poor and minority women.

9 May 2013

Researchers discover potential treatment for deadly, drug-resistant bacterial infections

Through the serendipity of science, researchers at the University of Pittsburgh have discovered a potential treatment for deadly, drug-resistant bacterial infections that uses the same approach that HIV uses to infect cells.

8 May 2013

Elixir Medical receives FDA approval to initiate patient enrollment in EXCELLA III clinical trial in US

Elixir Medical Corporation, a developer of products that combine state-of-the-art medical devices with advanced pharmaceuticals, announced today that it has received approval from the Food and Drug Administration to initiate patient enrollment in the EXCELLA III clinical trial in the United States at up to 50 institutions with conditions to be addressed in parallel.

8 May 2013

Handheld ultrasound device from Signostics receives 510K clearance from the FDA

Handheld ultrasound device manufacturer Signostics has received a major boost with 510(k) clearance from the US Food and Drug Administration (FDA) to market its new Signos RT to the lucrative American market.

7 May 2013

Aptiv Solutions participates in 'Practice Adaptive Clinical Trials’ conference at Tokyo University

Aptiv Solutions, a biopharmaceutical and medical device development services company and pioneer in adaptive clinical trial design, simulation and execution, announces its participation in a prestigious conference on adaptive clinical trials, held at the University of Tokyo on May 10th 2013.

7 May 2013

New report highlights factors that contribute to asthma

There is still no cure for asthma, so for 22 million people in the U.S., this chronic disease continues to be a daily burden no matter where they live. But it's not just air pollution they should be worried about. Factors such as pollen, secondhand smoke – even high rates of poverty, a large uninsured population or a high number of ER visits – can be critical signs that certain cities and states are worse for families with asthma. It is especially true for people with severe asthma.

7 May 2013

Medical Devices News and Research

CardioKinetix reports meta-analysis study results of Parachute Ventricular Partitioning Device

Viewpoints: Mass. experience may not be true test for national health law; 'Dishonest' campaign by medical device makers

Safety and efficacy evaluation methods for medical devices

Clinical data on Cook Medical products to be presented at Digestive Disease Week®

GfK to deliver major presentation on personalized medicine at PBIRG Annual General Meeting

Ambulatory syringe pump training: an interview with Ruth Goodwin RGN, BSc Clinical Education Manager for CME Medical

Elixir's DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System receives CE Mark approval

Search, Share, Spare campaign to raise awareness about breast cancer surgery options

Polymer substance fully resists the body's natural attack response to foreign objects

TriStar Wellness Solutions completes acquisition of HemCon Medical Technologies

HTSI to receive GE Healthcare-AACN Pioneering Spirit Award

Uroplasty highlights results of STEP Study on PTNS treatments for overactive bladder

Echo Therapeutics reports net loss of $7.0 million for first quarter 2013

Scientists use phages to prevent bacteria on medical devices

Federal judge criticizes FDA regarding Plan B contraception decision

Researchers discover potential treatment for deadly, drug-resistant bacterial infections

Elixir Medical receives FDA approval to initiate patient enrollment in EXCELLA III clinical trial in US

Handheld ultrasound device from Signostics receives 510K clearance from the FDA

Aptiv Solutions participates in 'Practice Adaptive Clinical Trials’ conference at Tokyo University

New report highlights factors that contribute to asthma

Industry Focus eBook - Medical Devices (3rd Edition) eBook

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

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