Medical Devices News and Research

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Policy flashpoints fuel reform debate

Kaiser Health News: "The health care overhaul debate in Congress now centers on two bills: the House-passed measure and the Senate Democrats' version unveiled Wednesday. They differ in important ways." KHN provides a consumers' guide that discusses mandates, new regulations on health insurers and how the legislation would affect both the insured and uninsured (Appleby, Carey, Galewitz and Rau, 11/19).

20 Nov 2009

Smith & Nephew signs a technology development contract with the U.S. Department of Defense

Smith & Nephew Orthopaedics Division is pleased to announce the signing of a technology development contract with the United States Department of Defense that may lead to the creation of a fracture fixation system intended to revolutionize the treatment of the limbs of soldiers who sustain battlefield injuries.

20 Nov 2009

FDA completes IIWA to curb illegal actions involving medical products

The U.S. Food and Drug Administration today completed a coordinated, weeklong, international effort, called the International Internet Week of Action (IIWA), intended to curb illegal actions involving medical products.

20 Nov 2009

CleveMed to distribute its products in Europe and Canada following receipt of the CE Mark and CMDCAS

CleveMed recently received ISO 13485 certification issued by BSI Management Systems America Inc., one of the foremost auditing bodies in the world. CleveMed has also received the CE Mark and CMDCAS allowing its products to be distributed to the large European and the Canadian markets which will strengthen its worldwide market presence.

19 Nov 2009

Senate health bill released, another step toward Democratic-backed reforms

"Senate Majority Leader Harry Reid set the stage for a climactic debate in the Senate over health care by unveiling a 10-year, $848 billion bill that would extend insurance to 31 million Americans without coverage," The Wall Street Journal reports.

19 Nov 2009

Vicor Technologies' PD2i nonlinear algorithm and software: a promising diagnostic for in-field trauma triage

David H. Fater, CEO of Vicor Technologies, Inc., today announced that Andriy Batchinsky, MD, a researcher with the U.S. Army Institute of Surgical Research (USAISR), identified Vicor's proprietary PD2i® nonlinear algorithm and software as the most promising diagnostic for in-field trauma triage during a presentation before several hundred attendees at the American Heart Association's Resuscitation Science Symposium 2009 on November 14, 2009 in Orlando, Florida.

19 Nov 2009

Astellas Pharma and XenoPort submit NDA in Japan for PMDA approval

Astellas Pharma Inc. and XenoPort, Inc. today announced that a new drug application (NDA) has been filed with the Pharmaceuticals and Medical Device Agency (PMDA) in Japan for ASP8825 (gabapentin enacarbil), also known as XP13512, as a potential treatment for restless legs syndrome (RLS).

19 Nov 2009

USP releases new CRMs for carbamazepine, phenytoin, and theophylline

To help bring greater certainty to the measurement of medication levels in a patient's bloodstream for three drugs with narrow therapeutic ranges, the U.S. Pharmacopeial Convention (USP) is releasing new certified reference materials (CRMs).

19 Nov 2009

China Medical Technologies announces financial results for second fiscal quarter

China Medical Technologies, Inc. (the "Company"), a leading China-based medical device company that develops, manufactures and markets advanced in-vitro diagnostic products, today announced its unaudited financial results for the second fiscal quarter ended September 30, 2009 ("2Q FY2009"). The Company's 2009 fiscal year ends on March 31, 2010 ("FY2009").

19 Nov 2009

BeamOne announces its newest electron beam medical device sterilization service center

BeamOne LLC announces that it will locate its newest electron beam medical device sterilization service center in the Pittsburgh, Pennsylvania area. Ground breaking will begin on the new facility in Q4 2009, and it is anticipated to be operational during Q4 2010.

19 Nov 2009

Endologix receives IDE conditional approval from FDA

Endologix, Inc., developer of minimally invasive treatments for aortic disorders, announced today that it has received Investigational Device Exemption (IDE) conditional approval from the United States Food and Drug Administration ("FDA") to begin a prospective, multicenter, randomized clinical trial for a bilateral percutaneous approach to endovascular abdominal aortic aneurysm repair (EVAR) utilizing the Company's IntuiTrak(TM) endovascular delivery system for the Powerlink® family of stent grafts.

19 Nov 2009

St. Jude Medical announces implantation of the first patient in China with its Eon rechargeable neurostimulator

St. Jude Medical, Inc. announced today that a 62-year-old man from Shenzhen, Guangdong province has become the first patient in China to be implanted with the Eon™ neurostimulator, a rechargeable device used to help manage chronic pain. Despite prior back surgeries, the patient suffered from chronic back pain for more than a decade.

18 Nov 2009

W. L. Gore to distribute QXMédical's Q50 Stent Graft Balloon Catheter

W. L. Gore & Associates today announced it has entered into a partnership with QXMédical, LLC, a medical device development and marketing company. As part of the agreement, Gore will distribute the Q50 Stent Graft Balloon Catheter which is designed for use with aortic stent grafts that treat abdominal aortic aneurysms (AAA) and thoracic aortic aneurysms (TAA).

18 Nov 2009

Third patent application for COPD stem cell therapy filed by Entest BioMedical

Entest BioMedical Inc. (OTC Bulletin Board: ENTB) announced today the filing of a third patent application relating to the area of chronic obstructive pulmonary disease (COPD), a condition that affects more than 5 million patients in the United States, resulting in more than 120,000 deaths per year. The application covers an implantable medical device useful in re-directing the immune system to stop tissue inflammation.

18 Nov 2009

Real time location system can make hospitals more efficient and improve patient care

Results from the first multidisciplinary university study examining the impact of a Real Time Location System (RTLS) deployed throughout a hospital show that the technology for tracking mobile medical equipment is driving increased operational efficiency and saving hundreds of thousands of dollars annually, while also enabling nurses to spend more time with patients and improve staff morale.

18 Nov 2009

Drug therapy offers substantial cost savings than angioplasty

Many patients with diabetes should forego angioplasties for heart disease and just take medicine instead, according to a new National Institutes of Health study led by Stanford University School of Medicine researcher Mark Hlatky, MD.

18 Nov 2009

Ellipse Technologies' MAGEC Technology for spinal deformity treatment receives CE Mark

Ellipse Technologies, Inc. announced today it has received CE Mark (Conformité Européenne) for its MAGECTM Technology for the treatment of spinal deformity. The first application for this technology is for the treatment of spinal scoliosis in young children and teenagers. The CE Mark allows the Company to market the MAGEC System in the European Union and other countries that recognize the CE Mark for commercial distribution purposes.

17 Nov 2009

American Biotech Labs' ASAP Antibacterial Silver Gel receives FDA 510(k) medical device clearance

American Biotech Labs, LLC (ABL), developer of a new class of products based on the company's patented nano-catalytic SilverSol Technology(R), today announced that the company has obtained clearance by the U.S. Food and Drug Administration (FDA) to market its ASAP Antibacterial Silver Wound Dressing Gel as a prescription 510(k) medical device throughout the United States. Clifton Mining Company is a major shareholder in American Biotech Labs.

17 Nov 2009

Presentations to highlight durability and efficacy of urethral bulking agents

Uroplasty, Inc. (AMEX: UPI), a medical device company developing, manufacturing and marketing innovative proprietary products for the treatment of voiding dysfunctions, today announced that nine abstracts outlining study results submitted by various researchers have been accepted for presentation at the 2010 Annual Meeting of the Society for Urodynamics and Female Urology (SUFU), February 23-27, 2010 in St. Petersburg, FL. Presentations accepted were for both Uroplasty's Urgent® PC Neuromodulation System and Macroplastique® urethral bulking agent products.

17 Nov 2009

Entellus Medical completes its Series D financing totaling $30MM

Entellus Medical, the Minnesota-based developer of novel, less invasive treatments for chronic conditions of sinusitis, has completed its Series D financing totaling $30MM. The Series D round was led by new investor Essex Woodlands Health Ventures and supported by existing investors Split Rock Partners and SV Life Sciences.

17 Nov 2009

Medical Devices News and Research

Policy flashpoints fuel reform debate

Smith & Nephew signs a technology development contract with the U.S. Department of Defense

FDA completes IIWA to curb illegal actions involving medical products

CleveMed to distribute its products in Europe and Canada following receipt of the CE Mark and CMDCAS

Senate health bill released, another step toward Democratic-backed reforms

Vicor Technologies' PD2i nonlinear algorithm and software: a promising diagnostic for in-field trauma triage

Astellas Pharma and XenoPort submit NDA in Japan for PMDA approval

USP releases new CRMs for carbamazepine, phenytoin, and theophylline

China Medical Technologies announces financial results for second fiscal quarter

BeamOne announces its newest electron beam medical device sterilization service center

Endologix receives IDE conditional approval from FDA

St. Jude Medical announces implantation of the first patient in China with its Eon rechargeable neurostimulator

W. L. Gore to distribute QXMédical's Q50 Stent Graft Balloon Catheter

Third patent application for COPD stem cell therapy filed by Entest BioMedical

Real time location system can make hospitals more efficient and improve patient care

Drug therapy offers substantial cost savings than angioplasty

Ellipse Technologies' MAGEC Technology for spinal deformity treatment receives CE Mark

American Biotech Labs' ASAP Antibacterial Silver Gel receives FDA 510(k) medical device clearance

Presentations to highlight durability and efficacy of urethral bulking agents

Entellus Medical completes its Series D financing totaling $30MM

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

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

Advancing Intracellular Delivery with LumiPore®

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