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EMKinetics initiates TranStim therapy pivotal trial for urge incontinence, overactive bladder

EMKinetics, Inc. announced today initiation of the TranStim Transdermal Neuromodulation System pivotal trial for patients suffering from urge incontinence and overactive bladder.

14 Oct 2011

Medical panels continue to wrestle with conflict-of-interest issues

Financial conflicts abound on medical panels that set practice guidelines. ... Researchers found conflicts of interest were prevalent among experts who served on 14 U.S. and Canadian panels that came up with guidelines for the treatment of diabetes and high cholesterol between 2000 and 2010. All told, 52 percent (or 150 of 288 people) had financial conflicts of interest.

14 Oct 2011

WuXi PharmaTech announces acquisition of Abgent

WuXi PharmaTech Inc., a leading pharmaceutical, biotechnology and medical device research and development services company with operations in China and the United States, today announced the acquisition of Abgent, Inc., a provider of biological research reagent products and services based in Suzhou, China, and San Diego, California.

14 Oct 2011

FDA grant to foster development of novel pediatric medical devices

The U.S. Food and Drug Administration (FDA) has awarded the Georgia Institute of Technology, Children's Healthcare of Atlanta, Emory University and Saint Joseph's Translational Research Institute (SJTRI) a two-year, $1.8 million grant to foster the development of medical devices focused on the special needs of children.

13 Oct 2011

Viewpoints: Screening for prostate cancer, stem cell research and free coverage for Iowa lawmakers

As a practicing internist, I need all the help I can get in diagnosing the many diseases that threaten the life and well-being of my patients. So perhaps you'll understand why I'm angered by the reckless new recommendations from the U.S. Preventive Services Task Force (a panel of primary care experts) that I don't use the prostate-specific antigen to screen men older than 40 for prostate cancer.

13 Oct 2011

New conference on Innovations in Medical Polymers

MPMN and PlasticsToday.com, both leading news and information providers for the medical device and plastics industry, today announced the launch of a new conference on Innovations in Medical Polymers, providing insights into the latest technological and regulatory developments in the use of polymers in medical devices.

11 Oct 2011

St. Jude Medical launches new Merlin.net Patient Care Network update

St. Jude Medical, Inc., a global medical device company, today announced the launch of its Merlin.net Patient Care Network (PCN) version 5.0. This update features enhancements to the Internet-based repository of patient and implantable device data that provide physicians easier access to important alerts and improve efficiency of data transmission to electronic health records.

11 Oct 2011

Viewpoints: Obama fighting back; putting a price on compassion; questions for GOP candidates

As part of his newfound assertiveness, President Obama is using the term "Obamacare," the Republicans' sneering dismissal of the Democratic health care reforms. We are skeptical that he will be able to turn it into a term of approbation. But it is heartening to see him finally out there defending his pioneering policy with no apologies and an uncharacteristic feistiness.

11 Oct 2011

Conflicts of interest sometimes emerge in ownership arrangements between physicians, medical device companies

The Wall Street Journal reports on how such arrangments sometimes create an incentive for surgeons to do more operations, which raises quality issues and health care costs.

11 Oct 2011

CMS, FDA launch 'parallel review' pilot program for medical devices

The U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services (CMS) today launched a "parallel review" pilot program for concurrent review of medical devices for FDA approval and Medicare coverage.

10 Oct 2011

New review explores how nanotechnology may develop safer breast implants

A new review published in WIREs Nanomedicine and Nanobiotechnology explores how nanotechnology may be used to develop safer breast implants as an alternative to silicone rubber, minimizing health complications.

4 Oct 2011

Phagenesis closes Series B funding

Phagenesis Ltd, the global leader in the treatment of dysphagia (inability to swallow safely) today announced that it has closed a €7 million Series B funding round designed to accelerate the company's development plans.

4 Oct 2011

CDRH report highlights scientific activities that support medical device industry

The U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) today released a report highlighting scientific activities that support the medical device industry and product development, while maintaining the safety and effectiveness of the products.

4 Oct 2011

Viewpoints: Mixing Obama and Ryan's plans, cancer rationing and stalling federal aid

What has been revealed is that the systems set up during an industrial era to provide health care, retirement income and support during economic downturns are inadequate for and ill-suited to our post-industrial, globalized economy. ...one can imagine a system in which all workers and nonworkers are required to buy insurance from the government-regulated exchanges being set up in each region or state under the Obama health-care reform plan.

4 Oct 2011

GETINGE to acquire Atrium Medical

Atrium Medical Corporation, announced today that it has signed a definitive agreement to be acquired by GETINGE GROUP of Sweden and its subsidiary, MAQUET Cardiovascular, a global leading provider of cardiovascular technologies for $680 million.

3 Oct 2011

FBC Device receives US patent titled, 'Disc Implant'

FBC Device ApS, a medical device company developing the Statur line of spinal interbody fusion implants, has received its first US patent covering a series of two piece implants that enable natural spinal alignment. The Patent number US 8,007,536 is titled "Disc Implant."

3 Oct 2011

Lifeline Biotechnologies to reestablish DTC services

Lifeline Biotechnologies, Inc. announced today that the Company continues efforts to reestablish DTC services.

1 Oct 2011

Subsidiary Acacia Research receives patents for heart valve technology

Acacia Research Corporation announced today that a subsidiary has acquired patents for heart valve technology from a major medical device company.

1 Oct 2011

Wireless Vital Signs Monitor for trauma victims enters clinical trial phase

A collaboration among a medical device innovator, the U.S. Army Institute of Surgical Research (ISR), the nonprofit National Trauma Institute and the State of Texas enters its final phase as the FDA-approved Wireless Vital Signs Monitor (WVSM) begins clinical trials this month in the Memorial Hermann Medical Center emergency department and on Houston Life Flight.

1 Oct 2011

JenaValve's transapical TAVI system receives CE mark approval to treat aortic valve stenosis

JenaValve Technology GmbH, a German medical device company specializing in the development of transcatheter heart valve implantation systems, announced today that the Company has received CE mark approval for its transapical TAVI system of the second-generation. This system is used to treat severe aortic valve stenosis in elderly high-risk patients, especially in patients for whom conventional open-heart surgery is not an option.

1 Oct 2011