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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 | News | 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...


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 | News | 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...


Encoder Designed for Extreme Electromagnetic Fields

August 26, 2010 8:10 am | Micronor Inc. | Product Releases | Comments

The MR318 Fiber Optic Rotary Encoder is the world's first and only commercially available, non-metallic rotary position sensor that can operate with complete "transparency" in extreme electromagnetic fields.


Socket Enables Testing of Serial to Parallel Data Convertor

August 26, 2010 8:00 am | Ironwood Electronics, Inc. | Product Releases | Comments

Ironwood Electronics recently introduced a new stamped spring pin socket addressing high performance requirements for testing UART serial to parallel data convertor, CBT-QFN-7002.

How to Respond to (and Avoid) FDA Form 483 Observations for Temperature, Humidity and Other Controlled Environments

August 26, 2010 7:57 am | by Ken Appel | White Papers

No cGMP manufacturer wants to receive a Form 483 letter (“Notice of Inspectional Observations”). In such stringently controlled industries as pharmaceutical/biotechnical/medical device development, manufacturing and warehousing, receiving a list of deficiencies can feel like a heavy blow to your quality system.

Catheter Manufacturing With Ultrasonic Welder

August 26, 2010 7:52 am | Product Releases | Comments

Herrmann Ultrasonics has developed a uniquely configured, semi automated machine, to meet the challenges of ultrasonic welding this particular type of medical product.

Embedded Opportunity: Dynamics of Medical Device Evolution Driving Need for Static Analysis

August 26, 2010 7:46 am | by Klocwork | White Papers

Evolving end-user expectations for differentiated software functionality, sustained time-to-market, and cost pressures continue to fuel new software development within embedded devices. Time-to-market and cost considerations will continue to drive embedded systems manufacturers to utilize international engineering resources and legacy code assets whenever efficient and economical.

Mass. reaches $1.35M settlement with biotech co.

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


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

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


CareFusion Announces National Launch of Spinal Fracture Device

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


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

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


DePuy Orthopaedics Voluntarily Recalls ASRâ„¢ Hip System

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


LED Delivers Lighting Class Performance

August 26, 2010 7:26 am | Cree Inc | Product Releases | Comments

The MX-3 LED extends Cree's lighting-class performance to a broader set of applications with enhanced light uniformity and LED-to-LED color consistency.

Insurer Humana names CEO McCallister as chairman

August 26, 2010 6:45 am | by The Associated Press | News | Comments

Health insurer Humana Inc. on Thursday named long-standing CEO Michael B. McCallister as chairman, succeeding David A. Jones Jr. who has resigned from the post but will remain on the board.The Louisville, Ky., company did not say why Jones chose to step down. Jones is founder and managing...


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