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Luminex Announces Commercial Launch of New Cystic Fibrosis Test

August 26, 2010 12:33 pm | by Bio-Medicine.Org | Comments

AUSTIN, Texas, Aug. 26 /- Luminex Corporation (Nasdaq: LMNX ), the worldwide leader in multiplexed solutions, today announced the full commercial launch of its xTAG® Cystic Fibrosis 60 Kit v2, a new diagnostic test that can simultaneously screen a single blood sample for up to 60...

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Fingerstick Devices to Obtain Blood Specimens: Initial Communication - Risk of Transmitting Bloodborne Pathogens

August 26, 2010 12:31 pm | by U.S. Food & Drug Administration | Comments

Increase in reports of bloodborne infection transmission resulting from the shared use of fingerstick and point-of-care blood testing devices.

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Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication

August 26, 2010 10:32 am | by U.S. Food & Drug Administration | Comments

CDC and FDA have noted a progressive increase in the reports of bloodborne infection transmission over the past 10 to 15 years (primarily hepatitis B virus), resulting from the shared use of fingerstick and POC blood testing devices...

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Stryker Biotech to pay $1.35M settlement to Mass.

August 26, 2010 8:34 am | by Mass High Tech: The Journal of New England Technology | Comments

The Massachusetts state attorney general's office has settled with Stryker Biotech LLC over allegations the company improperly marketed orthopedic products for indications that were not approved by the U.S. Food and Drug Administration.

Frankfurt am Main Emergency Medical Services Makes Masimo Rad-57 Pulse CO-Oximeters Mandatory for All Vehicles

August 26, 2010 8:33 am | by Bio-Medicine.Org | Comments

IRVINE, Calif., Aug. 26 /- Frankfurt am Main Emergency Medical Services (EMS) in Germany and Masimo (Nasdaq: MASI ), the inventor of rainbow® Pulse CO-Oximetry™, rainbow Acoustic Monitoring™, and Masimo SET® Measure-Through Motion and Low Perfusion pulse oximetry,...

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Society of Interventional Radiology Supports Research for New M.S. Treatments

August 26, 2010 8:33 am | by Bio-Medicine.Org | Comments

FAIRFAX, Va., Aug. 26 /PRNewswire-USNewswire/ -- Recognizing that venous interventions may potentially play an important role in treating some patients who suffer from multiple sclerosis -- an incurable, disabling disease -- the Society of Interventional Radiology has issued a position...

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Endologix Receives CE Mark Approval for Expanded Line of Powerlink Products and PowerFit Aortic Extensions

August 26, 2010 8:33 am | by Bio-Medicine.Org | Comments

IRVINE, Calif., Aug. 26 /- Endologix, Inc. (Nasdaq:  ELGX), developer of minimally invasive treatments for aortic disorders, announced today that it received CE Mark approval to market its expanded offering of Powerlink® stent graft products and PowerFit™ Aortic Extensions...

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Safety Investigation of Non-Coring (Huber) Needles: Updated August 26, 2010

August 26, 2010 8:31 am | by U.S. Food & Drug Administration | Comments

Huber needles are used to access ports implanted under the skin of chronically ill patients for repeated access to veins for the withdrawal of blood and infusion of medication, nutritional solutions, blood products, and imaging solutions...

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Class I Medical Device Recall: Multi-Med, Inc., 22 Gauge x 1 inch Straight and Right Angle Huber Needles and Navilyst Medical Inc., Vaxcel Implantable Vascular Access Systems ...

August 26, 2010 8:30 am | by U.S. Food & Drug Administration | Comments

Huber needles are safety needles used on vascular access ports implanted in patients in need of repeated intravenous therapy. A "coring" Huber needle could damage the implanted port by removing silicone slivers from the access membrane...

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Mass. reaches $1.35M settlement with biotech co.

August 26, 2010 7:45 am | by The Associated Press | Comments

Massachusetts officials say a biotech company has agreed to pay $1.35 million to resolve allegations that it marketed medical products for purposes that had not been approved by regulators.Attorney General Martha Coakley said in a statement Thursday that Hopkinton-based Stryker Biotech had...

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Bio-Reference Labs' fiscal 3Q profit jumps 24 pct

August 26, 2010 7:45 am | by The Associated Press | Comments

Bio-Reference Laboratories Inc. said Thursday its fiscal third-quarter net income jumped 24 percent, as the clinical laboratory testing services provider increased the number of patients served and its revenue per patient.The Elmwood Park, N.J., company earned $8 million, or 29 cents per share,...

Black rice rivals pricey blueberries as source of healthful antioxidants

August 26, 2010 7:33 am | by EurekAlert | Comments

(American Chemical Society) Health conscious consumers who hesitate at the price of fresh blueberries and blackberries, fruits renowned for high levels of healthful antioxidants, now have an economical alternative. It is black rice, one variety of which got the moniker "forbidden...

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CareFusion Announces National Launch of Spinal Fracture Device

August 26, 2010 7:32 am | by Bio-Medicine.Org | Comments

SAN DIEGO, Aug. 26 /- CareFusion (NYSE: CFN ), a leading, global medical device company, today announced the national commercial launch of the AVA max® Vertebral Balloon, a minimally invasive device for use during kyphoplasty, a procedure for treating spinal compression fractures....

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World's Tallest Man Stretches Out for Needed Gamma Knife Surgery

August 26, 2010 7:32 am | by Bio-Medicine.Org | Comments

ATLANTA, Aug. 26 /- Much of Sultan Kosen's eight feet, two-inch stature rose up in an 17-year period starting at age 10, when the benign tumor in his brain's pituitary gland highjacked the organ, causing it to secrete massive amounts of growth hormone, making Mr. Kosen's body grow fast...

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DePuy Orthopaedics Voluntarily Recalls ASRâ„¢ Hip System

August 26, 2010 7:31 am | by Bio-Medicine.Org | Comments

WARSAW, Ind., Aug. 26 /- DePuy Orthopaedics, Inc., announced it is voluntarily recalling the ASRâ„¢ XL Acetabular System and DePuy ASRâ„¢ Hip Resurfacing System used in hip replacement surgery due to the number of patients who required a second hip replacement procedure, called a...

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