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FDA approves Medtronic Endurant AAA Stent Graft System for abdominal aortic aneurysms

An estimated 1.2 million people in the United States have an abdominal aortic aneurysm (AAA) - a dangerous bulge or ballooning in their bodies' main artery that typically causes no symptoms until it ruptures, which can be deadly - and most of them don't know it. But for those with a known AAA of a certain size, there's a new medical device for a safe and effective treatment option that doesn't require major surgery, an extended hospital stay and a long recovery period.

21 Dec 2010

Opsens unveils EasyWire for growth market of Fractional Flow Reserve for coronary lesion assessment

Opsens Inc. today unveiled the EasyWire, developed by its medical division for the growth market of Fractional Flow Reserve for coronary lesion assessment.

20 Dec 2010

Spartan RX CYP2C19 DNA testing system receives European CE Mark certification

Spartan Bioscience Inc., a privately held molecular diagnostics company that develops, manufactures, and markets DNA testing systems for on-demand applications, today announced its Spartan RX CYP2C19 received a CE IVD Mark under the European Directive on In Vitro Diagnostic Medical Devices. The CE Mark certification allows commercial distribution in Europe as well as in all countries recognizing the CE Mark in the Middle East, Africa, Latin America, and Asia-Pacific regions.

20 Dec 2010

Exosomes derived from lymphoma, colorectal cancer patients circulated through Aethlon's Hemopurifier

Aethlon Medical, Inc., the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that it has demonstrated the ability to capture immunosuppressive exosomes derived from individuals with lymphoma and colorectal cancer.

20 Dec 2010

PwC: Top Health Industry Issues of 2011

Health organizations will undergo a strategy makeover in 2011 as they react to new rules and payment models, continuing cost pressures and new customer demands, according to the Top Health Industry Issues of 2011, published today by PwC's Health Research Institute. But in a recent nationwide survey of 1,000 U.S. adults, PwC found that consumers don't fully understand or buy-in to all the changes.

20 Dec 2010

FFR-guided percutaneous coronary intervention provides cost-saving benefits

St. Jude Medical, Inc., a global medical device company, today announced the publication of results from an economic evaluation of the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) trial, which confirmed FFR-guided percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease improves patient outcomes and offers cost-saving benefits to the U.S. healthcare system.

17 Dec 2010

MedicAlert Foundation's 'Code of Conduct' helps evaluate integrity of emergency medical information

The non-profit MedicAlert Foundation published a "Code of Conduct" in an effort to help consumers evaluate the integrity of organizations providing emergency medical information and identification services. In addition, as part of the "Code of Conduct" the Foundation has established business practice standards for medical information and identification service organizations that house consumer health information. Across the country millions of consumers are using personal health records, emergency medical information services, personal medical alarms systems or medical identification jewelry services.

16 Dec 2010

Oxygen Biotherapeutics and SMP sign Binding Letter of Intent for joint chronic ischemic wound research

Oxygen Biotherapeutics, Inc. and privately held Sarasota Medical Products, Inc. (SMP) of Sarasota, FL, today announced they signed a Binding Letter of Intent to determine the feasibility of pursuing a joint research and development venture for treating chronic ischemic wounds. The venture will be based on combining Oxygen's Wundecyte™ PFC formulation with SMP's topical medical devices.

16 Dec 2010

The Baltimore Sun: Stent sellers were allowed inside lab despite hospital ban

News outlets examine how the marketing of medical devices and treatments impacts health care costs and physicians' decisions.

16 Dec 2010

PharmaNet launches Initiator and PKS technology platforms to improve clinical study timelines

PharmaNet Development Group, Inc., a leading provider of clinical development services to pharmaceutical, biotechnology, generic drug and medical device companies, is pleased to announce that it is launching two technology platforms – Initiator™ and PKS™ - that will provide dramatic improvements in clinical study timelines by accelerating data acquisition and the processing of final client reports in its Phase I clinics. By providing clients with real time data faster, sponsors can make informed decisions about their products earlier in the process.

15 Dec 2010

Demand for clinical research professionals double

ResourcingPoint announces that demand for clinical research professional placement has doubled in the last two months. An increase in clinical activity across the industry, coupled with a strategic expansion of the ResourcingPoint database of professional staff, has enabled significant clinical outsourcing growth for the company. A variety of different companies, from emerging device to large pharma and CROs, rely on ResourcingPoint for their contracting needs.

15 Dec 2010

AzTe and Zcube: Innovative treatment of chronic respiratory diseases

Zcube, Srl, the research venture of Italian pharmaceutical company Zambon Co., SpA, and Arizona Technology Enterprises (AzTE), the technology venturing arm of Arizona State University, have entered into a licensing agreement that will allow Zcube to use ASU technology to develop and commercialize next-generation medical devices that can better monitor and treat chronic respiratory diseases like asthma.

15 Dec 2010

Smiths Medical launches Medfusion 4000 wireless syringe infusion pump with PharmGuard systems in Canada

Smiths Medical, a leading global medical device manufacturer, announced today it received a license from Health Canada and launched its Medfusion® 4000 syringe infusion pump with the PharmGuard® software suite in Canada. The new customizable system allows health care providers to send and receive medication delivery information more efficiently, helping to prevent medication errors.

15 Dec 2010

Synergetics launches next generation of Codman Malis electrosurgical generator

Synergetics USA, Inc., a medical device company that designs, manufactures, and markets innovative products for ophthalmic and neurosurgical applications, has introduced the CMC® V, the next generation of the Codman® Malis® electrosurgical generator. Codman & Shurtleff, Inc. is the exclusive distributor of the CMC® V. CMC and Codman are registered trademarks of Johnson & Johnson Corporation.

15 Dec 2010

Natural Prosthetic Dental Lab launches 'Digital revolution of dentistry'

News briefs concerning economic and business growth in the Tampa Bay region from the Tampa Bay Partnership:

14 Dec 2010

State roundup: New Dem Gov. and Minn. Medicaid; Fla. docs on Medicaid changes; Iowa Gov. eyes long-term care loopholes; Conn. provider rates

Over the past decade, programs that integrate Medicaid and Medicare have resulted in improved consumer satisfaction, better health outcomes and lower Medicaid costs in Arizona, Massachusetts, Minnesota, New Mexico, New York, Wisconsin and Washington. In each case, states have had to change their Medicaid rules by attaining a waiver from the federal government (Vestal, 12/13).

13 Dec 2010

iMDsoft, Mindray enter new distribution agreement

iMDsoft®, a leader in hospital-wide clinical information systems, and Mindray, a leading global provider of medical devices, have today announced a new distribution agreement. Under the agreement, Mindray will sell only clinical information systems by iMDsoft, and will be the sole distributor of MetaVision® in China. Mindray will also distribute iMDsoft's MetaVision® Suite solutions in 10 countries in Europe, Africa, and Asia.

From Mindray 13 Dec 2010

FDA clears Clear Catheter Systems' PleuraFlow Active Tube Clearance System

Clear Catheter Systems, Inc., a Bend, Oregon-based medical device company, announced today that it has received US Food and Drug Administration clearance for its innovative PleuraFlow™ Active Tube Clearance System. This is a device that can be widely deployed in the post operative management of patients requiring heart and lung surgery.

13 Dec 2010

NinePoint enters IP licensing agreement with Massachusetts General Hospital

NinePoint Medical, Inc., an emerging leader in the development of in vivo pathology medical devices, today announced it has entered into an intellectual property (IP) licensing agreement with Massachusetts General Hospital (MGH). Under the agreement, NinePoint has certain exclusive rights in multiple fields to 188 patents and patent applications owned by MGH.

13 Dec 2010

Stimatix GI's AOS-C1000 colostomy management device meets primary, secondary endpoints in pre-clinical studies

Stimatix GI reported that the AOS-C1000(TM), a unique colostomy management device, met primary and secondary endpoints in pre-clinical in-vivo animal studies. The study was conducted under the direction of Dr. Ron Greenberg, Senior Surgeon, Department of Surgery, Sourasky Medical Center, Tel Aviv Israel. Primary endpoints of repeatable stoma sealing for continence control as well as secondary endpoints regarding tissue pathology and survival were met confirming the AOS-C1000(TM) as capable of enabling repeatable colostomy site (stoma) sealing for continence control.

13 Dec 2010

Medical Devices News and Research

FDA approves Medtronic Endurant AAA Stent Graft System for abdominal aortic aneurysms

Opsens unveils EasyWire for growth market of Fractional Flow Reserve for coronary lesion assessment

Spartan RX CYP2C19 DNA testing system receives European CE Mark certification

Exosomes derived from lymphoma, colorectal cancer patients circulated through Aethlon's Hemopurifier

PwC: Top Health Industry Issues of 2011

FFR-guided percutaneous coronary intervention provides cost-saving benefits

MedicAlert Foundation's 'Code of Conduct' helps evaluate integrity of emergency medical information

Oxygen Biotherapeutics and SMP sign Binding Letter of Intent for joint chronic ischemic wound research

The Baltimore Sun: Stent sellers were allowed inside lab despite hospital ban

PharmaNet launches Initiator and PKS technology platforms to improve clinical study timelines

Demand for clinical research professionals double

AzTe and Zcube: Innovative treatment of chronic respiratory diseases

Smiths Medical launches Medfusion 4000 wireless syringe infusion pump with PharmGuard systems in Canada

Synergetics launches next generation of Codman Malis electrosurgical generator

Natural Prosthetic Dental Lab launches 'Digital revolution of dentistry'

State roundup: New Dem Gov. and Minn. Medicaid; Fla. docs on Medicaid changes; Iowa Gov. eyes long-term care loopholes; Conn. provider rates

iMDsoft, Mindray enter new distribution agreement

FDA clears Clear Catheter Systems' PleuraFlow Active Tube Clearance System

NinePoint enters IP licensing agreement with Massachusetts General Hospital

Stimatix GI's AOS-C1000 colostomy management device meets primary, secondary endpoints in pre-clinical studies

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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