safety

New da Vinci Surgical Robot to Hit Market in 2015

Though the manufacturer has come under fire for defective devices in the past, this year the da Vinci Sp Intuitive single port robot system used in surgical procedures is expected to hit the consumer market, according to MedGadget.com. The system is designed to allow for single-incision surgeries, and is a competitor to manufacturing giant Titan.
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Invasive Procedure Equipment Causes Big Problems When Contaminated

With cancer rates at an all-time high and cancer remaining a leading cause of death in the United States, the word biopsy has become a household term.  A biopsy, according to WebMD, is the examination of a contaminated tissue that was removed from the body to determine what disease—or to what extent the disease is present—is afflicting a patient. A patient will undergo a biopsy if he or she has abnormal test results or if a medical practitioner suspects that it could identify an unidentified condition.
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Why the FDA Removes Drugs from the Market

The U.S. Food and Drug Administration (FDA) controls what drugs may be sold or prescribed to the public. If a prescription drug is proven to cause dangerous side effects, FDA may remove it from the market. Also, the FDA may ask the manufacturer to withdraw a drug when the drug is not used in treatment anymore. There are a number of reasons why the FDA sometimes chooses to remove a drug off the market, according to this article. Here are two of them.
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New Surgery Robot under Scrutiny by FDA

A new trend in operating rooms across the United States and the world is a robot named Da Vinci.  This expensive multi-armed machine was approved by the FDA nearly four years ago to assist with highly dangerous surgeries like prostate removal, heart valve replacement and the transplantation of organs.  In fact, nearly 400,000 surgeries have been performed with da Vinci across the United States, wh
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Off-Label Prescriptions of Medications Prompts Caution

Modafinil is a medication that was created to treat shift work sleep disorder, narcolepsy and excessive sleepiness during the day as created by sleep apnea.  This drug is only approved by the FDA to treat those symptoms.   It works in a similar manner as a stimulant but because its effects on the human bodies are different, it is often referred to as a “wakefulness promoting agent”.
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FDA Recall for St. Jude Medical’s Amplatzer TorqVue FX

According to a recent article published by www.massdevice.com, St. Jude’s has recalled their Amplatzer TorqVue FX delivery system because of concerns about fractures in the core wire. The FDA has issued the highest-risk label on the recall of the delivery system produced by St. Jude Medical.
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Doctor Says New Medical Device May Not Be Safe

The new lead free implantable heart defibrillator, invented by Boston Scientific Corp, should not be used on a regular basis until more data is available, according to a story in the Chicago Tribune. Defibrillator leads have often caused problems for device makers.
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  • Newland & Newland LLP, Attorneys, Arlington Heights, IL
  • Lawyer.com