Medical Devices News and Research

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Insurer sees coming health insurer 'oligopoly,' doctors band together on system changes

Bloomberg Businessweek reports that health insurer WellPoint's investor-relations chief said Thursday that health insurers are "moving towards an oligopoly" accelerated by the new law. "New regulations on administrative spending and premium increases will push some independent insurers out of business or into deals with bigger rivals, said Michael Kleinman, vice president for investor relations, at a Wells Fargo & Co. conference in Boston.

28 Jun 2010

St. Jude Medical's Therapy Cool Path Ablation Catheter receives Japanese MHLW approval

St. Jude Medical, Inc., a global medical device company, today announced Japanese Ministry of Health, Labour and Welfare approval and reimbursement approval of its Therapy Cool Path Ablation Catheter. This marks the company's first entry into the irrigated catheter ablation market in Japan.

25 Jun 2010

Patient enrollment completed in pilot study of CyPath labeling solution for early detection of lung cancer

Cancer diagnostics company Biomoda, Inc. today announced it completed patient enrollment and sample collection in a pilot study to determine the clinical sensitivity and specificity of its CyPath labeling solution for the early detection of lung cancer. Top-line data and results will be released when available.

25 Jun 2010

Medicare to use new fraud identification tool

Gov Info Security: "The Centers for Medicare & Medicaid Services is the first agency to use a new fraud mapping tool that ultimately will be used throughout the federal government.

25 Jun 2010

IDEV enters exclusive distribution agreement with TriReme for GliderXtreme PTA balloon catheter

IDEV Technologies, Incorporated (IDEV), an emerging leader in the development and marketing of minimally invasive medical technologies, today announced that it has entered into an exclusive distribution agreement covering the U.S. and Germany for TriReme Medical, Inc.'s (TriReme) GliderXtreme™ PTA balloon catheter, an advanced product with specific features for the expanding Peripheral Arterial Disease (PAD) market.

24 Jun 2010

SPS receives $2.2M NHLBI grant to commercialize steerable cardiac mapping, ablation catheter technology

Strategic Polymer Sciences, Inc. (SPS), an innovator in advanced medical devices based on its proprietary electroactive polymer (EAP) technology, today announced it has received a $2.2 million grant from the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH). The SPS grant is one of only ten awarded nationwide by the NIH under a Recovery Act Limited Competition called The Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Pilot Program.

23 Jun 2010

WFIRM chooses Blue Mountain Regulatory Asset Manager to manage activities for clinical manufacturing center

Blue Mountain Quality Resources, Inc. (State College, PA) announced today that Wake Forest Institute for Regenerative Medicine has chosen Blue Mountain Regulatory Asset Manager to manage and document activities for its clinical manufacturing center.

23 Jun 2010

Healthcare technology innovation projects to receive $3M in CIMIT medical research grants

A wide variety of early-stage, healthcare technology innovation projects in NeuroHealth, Traumatic Stress Disorders, and integrated clinical environments were among those chosen to receive more than $3 million in CIMIT seed grants for FY11.

23 Jun 2010

iCAD image analysis software program used in DCE-MRI studies demonstrated at ASCO 2010

ACR Image MetrixTM, an imaging contract research organization with expertise in imaging trial design, techniques and data extraction, in conjunction with its software partner, iCAD, gave demonstrations of the iCAD image analysis software program used in DCE-MRI studies at the ACR Image Metrix booth during the 2010 Annual American Society of Clinical Oncology Meeting, which took place June 4-8, 2010, in Chicago, IL.

23 Jun 2010

Neurologix announces positive results from Phase 2 trial of NLX-P101 for advanced PD

Neurologix, Inc., today announced positive results in a Phase 2 trial of its investigational gene therapy for advanced Parkinson's disease, NLX-P101. Study participants who received NLX-P101 experienced statistically significant and clinically meaningful improvements in off-medication motor scores compared to control subjects who received sham surgery.

22 Jun 2010

USPTO issues patent related to Derma Sciences' MEDIHONEY Calcium Alginate Dressing

Derma Sciences, Inc., a medical device and pharmaceutical company focused on advanced wound care, announces that the U.S. Patent and Trademark Office has issued patent No. 7,714,183 related to the Company's MEDIHONEY Calcium Alginate Dressing.

22 Jun 2010

New report measures growing adoption of centralized ECG services

ERT, a global provider of technology and services to the pharmaceutical, biotechnology and medical device industries, announced today the availability of a new report, conducted by the Tufts Center for the Study of Drug Development, mapping the growing adoption of centralized ECG (electrocardiogram) services. The industry-wide report measures the current and anticipated adoption levels of centralized ECGs in clinical trials.

22 Jun 2010

FDA to hold workshop on medical device innovation to address unmet public health needs

Each day, medical devices from renal dialysis machines to implantable defibrillators help prevent, diagnose, treat, and monitor serious and life-threatening diseases. After taking years to develop, these devices then undergo a regulatory review process before entering the marketplace. It then takes even more time for them to be adopted into clinical practice and for patients to realize the benefits.

22 Jun 2010

Lack of tracking of medical devices' performance raises questions about safety and efficacy

"Amid the booming use of artificial joints in the United States, the breakup between Dr. Berger and Zimmer highlights what experts say is a troubling situation for patients and doctors: when disputes arise about orthopedic implant safety, there are no independent referees or sources of information because no one tracks the performance of the devices.

22 Jun 2010

Millar, Telemetry Research partner to offer TRM53P implantable transmitters

Millar Instruments, Inc., a medical device manufacturing firm and developer of pressure sensing technology, has released the TRM53P implantable transmitter through the partnership with Telemetry Research, Ltd. The TRM53P is the world's first, fully implantable transmitter that combines Millar's gold standard solid-state pressure sensors with Telemetry Research's next generation telemetry technology.

21 Jun 2010

First Edition: June 21, 2010

Today's news includes an exploration of the impact of Medicare payment rates on physicians, an analysis of the fate of the COBRA subsidy and how an innovation may offer a medical malpractice fix.

21 Jun 2010

Ingen Technologies to exhibit, sponsor at upcoming Medtrade conference

Ingen Technologies, Inc., a medical device manufacturer with an emerging new medical product line for the $8B respiratory market, announced today that the company has officially accepted to be an exhibitor and sponsor at the upcoming Medtrade conference in Atlanta, Georgia from November 15-18, 2010 at the Georgia World Congress Center.

19 Jun 2010

Health Robotics announces new Canadian marketing contracts for i.v.STATION, i.v.SOFT

Health Robotics announced that its joint-venture Health Robotics Canada Inc. (HRCI), a leading Canadian Pharmaceutical Company, and a well-established Quebec-based Medical Device Technology company have all recently signed marketing agreements in order to expand into Canada the market presence of i.v.STATION and i.v.SOFT, revolutionary technologies that provide automated sterile compounding of intravenous medications and parenteral nutrition to hospitals.

19 Jun 2010

PSC receives accreditation under UL's Data Acceptance Program to serve lighting and medical device industries

Following the successful completion of a rigorous audit by Underwriters Laboratories (Northbrook, IL) this month, Product Safety Consulting, Inc. (Bensenville, IL) announced today that they have received formal accreditation under UL's Data Acceptance Program to better serve two vibrant and growing sectors of the American economy: lighting products and medical devices.

19 Jun 2010

CPRIT awarded $142M in grants to fund cancer research and prevention programs across the state

The Cancer Prevention and Research Institute of Texas today awarded $142 million in grants to fund innovative cancer research and prevention programs across the state. Today's announcement caps the first year of the Institute's ten year mission. Together with matching funds committed by grant recipients, more than $300 million has been invested this year in Texas' extraordinary endeavor to change the face of cancer.

19 Jun 2010

Medical Devices News and Research

Insurer sees coming health insurer 'oligopoly,' doctors band together on system changes

St. Jude Medical's Therapy Cool Path Ablation Catheter receives Japanese MHLW approval

Patient enrollment completed in pilot study of CyPath labeling solution for early detection of lung cancer

Medicare to use new fraud identification tool

IDEV enters exclusive distribution agreement with TriReme for GliderXtreme PTA balloon catheter

SPS receives $2.2M NHLBI grant to commercialize steerable cardiac mapping, ablation catheter technology

WFIRM chooses Blue Mountain Regulatory Asset Manager to manage activities for clinical manufacturing center

Healthcare technology innovation projects to receive $3M in CIMIT medical research grants

iCAD image analysis software program used in DCE-MRI studies demonstrated at ASCO 2010

Neurologix announces positive results from Phase 2 trial of NLX-P101 for advanced PD

USPTO issues patent related to Derma Sciences' MEDIHONEY Calcium Alginate Dressing

New report measures growing adoption of centralized ECG services

FDA to hold workshop on medical device innovation to address unmet public health needs

Lack of tracking of medical devices' performance raises questions about safety and efficacy

Millar, Telemetry Research partner to offer TRM53P implantable transmitters

First Edition: June 21, 2010

Ingen Technologies to exhibit, sponsor at upcoming Medtrade conference

Health Robotics announces new Canadian marketing contracts for i.v.STATION, i.v.SOFT

PSC receives accreditation under UL's Data Acceptance Program to serve lighting and medical device industries

CPRIT awarded $142M in grants to fund cancer research and prevention programs across the state

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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