- Armand Rossetti | September 25, 2008 3:17 PM |
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Medical Devices & ImplantsOne might expect a medical device company on the prowl for profit, and steeped in the notion that anything goes in the quest to stifle the competition and dominate the market...to offer doctors a...
- Armand Rossetti | September 17, 2008 4:29 PM |
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Defective & Dangerous ProductsThe Yin:
As the old saying goes, there are two sides to every story. Today, an article appeared in the Journal of the American Medical Association (JAMA) raising new concerns about a unexpected...
- John Hopkins | September 17, 2008 3:58 PM |
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Miscellaneous
Everyone has read about or heard newscasts related to the
financial problems being experienced by AIG Insurance Group. Insurance companies and financial institutions have failed relatively...
- Armand Rossetti | September 17, 2008 1:58 PM |
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Medical Devices & ImplantsThe relatively new medical device is gadolinium-based contrast agent (GBCA or gadolinium) used during certain MRI or similar procedures. The new kidney related disease that is little more than a...
- Armand Rossetti | September 16, 2008 4:36 PM |
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FDA & Prescription DrugsThis is an explanatory statement taken directly from the FDA Website:
"The U.S. Food and Drug Administration has issued two Warning Letters to Ranbaxy Laboratories, Ltd., an India-based...
- Armand Rossetti | September 16, 2008 2:54 PM |
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Medical Devices & ImplantsLaurie Carpenter posted the following comment about my recent Fosamax blog, "What's the Story with Fosamax (Alendronate):
"this info would be helpful if put into lay terms for patients being...
- Armand Rossetti | September 16, 2008 12:33 PM |
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Medical Devices & ImplantsPhysio-Control (Physio), a wholly owned subsidiary of Medtronic Corporation has distributed over 650,000 automated external defibrillators (AEDs), worldwide and it holds more than 70% of the...
- Armand Rossetti | September 15, 2008 2:37 PM |
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Defective & Dangerous ProductsThat is a complex question for which there is no easy answer. However, it might help for us to gain a basic understanding of Fosamax’s composition; the specialized way that it works; and how the...
- Armand Rossetti | September 12, 2008 1:35 PM |
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MiscellaneousThe Medtronic Sprint Fidelis lead is the small subset of Class III device approved under the more stringent FDA PMA process. Therefore, barring any further federal legislation that would revise the...
- Armand Rossetti | September 11, 2008 2:42 PM |
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FDA & Prescription DrugsTequin is an antibiotic used to treat adults with lung, sinus, or urinary tract infections and also to treat certain bacterially generated, sexually transmitted diseases.
In recent years,...
- Brenda Fulmer | September 11, 2008 9:48 AM |
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FDA & Prescription DrugsLast week, the FDA ordered that warnings for several popular arthritis drugs be strengthened once again due to concerns about increased risks of life-threatening fungal infections. The new warnings...
- Armand Rossetti | September 10, 2008 3:21 PM |
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Medical Devices & ImplantsIn Riegel v. Medtronic, 552 US ___(2008), the Court stated that in 2005, the FDA authorized the marketing of 3,148 medical devices under §510(k), and granted premarket approval (PMA) to just 32...
- Armand Rossetti | September 10, 2008 11:06 AM |
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Medical Devices & ImplantsIn the May edition of Eye & Contact Lens 34(5): 247-253, 2008 entitled, “Acanthamoeba: A Review of Its Potential to Cause Keratitis, Current Lens Care Solution Disinfection Standards and...
- Armand Rossetti | September 09, 2008 2:32 PM |
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Miscellaneous
Today, when Americans use defective products that cause injury they have a remedy. Injured consumers usually sue the product’s manufacturer in state court. However, this opportunity for the courts...
- Armand Rossetti | September 07, 2008 2:47 PM |
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Medical Devices & ImplantsProbably the best people to ask are Senator Charles Grassley (R-IA), Ranking Member of the Committee on Finance that includes Medicare and Medicaid oversight, and Senator Herb Kohl (D-WI), Special...
- Armand Rossetti | September 04, 2008 11:48 AM |
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Medical Devices & ImplantsToday, the FDA webcast a notice that it has approved a Medtronics software update, designed to identify potential defibrillator lead fractures. You can access that notice here.
- Cal Warriner | September 02, 2008 6:10 PM |
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MiscellaneousA very recent laboratory study conducted at Stanford University heavily suggests that common anesthetics used in pain pumps cause significant tissue destruction. The study, prompted by poor outcomes...