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The FDA has issued the guidance, "In Vitro Diagnostic Devices to Detect Influenza A Viruses: Labeling and Regulatory Path," to inform industry and agency staff of recommended steps to ensure the safe and effective use of in vitro diagnostic (IVD) devices intended for use in the detection of influenza A viruses from humans.
In Vivo Metrics Systems, a manufacturer of cutaneous electrodes, received a warning letter from the FDA about devices the agency deems "adulterated" due to nonconformance with good manufacturing practices (GMPs).
The Gibson Group is pleased to announce the launch of interceptCS, an innovative device that completely revolutionizes the management of cold sores (herpes simplex -1).
Early intervention and long-term treatment with electrical
stimulation, which causes muscle contraction and exerts mechanical loading on the targeted bone, can significantly reduce the severe osteoporosis and muscle atrophy caused by spinal cord injury, according to University of Iowa researchers.
For several years, clinicians and computer scientists in the U.S. and abroad have been trying to improve cancer care -- from diagnosis to treatment -- by building vast, interconnected databases full of patient information.
Hospitech Resources Bhd is anticipating 60 per cent revenue growth in the financial year ending February 2007, to be driven by a bigger export market, better products, process improvement, higher efficiency and competitive pricing.
Dianna Cramer of Fairmount, Ill., is happy and relieved that her two boys, ages 14 and 9, will soon have health insurance, thanks to a new program that makes it available to all uninsured children in Illinois, no matter their family income.
The FDA has received numerous media inquires about a recently published paper reporting increased risk of malignant brain tumor associated long-term use of cell phones and cordless phones.
Boston Scientific has entered into an agreement containing consent orders with the staff of the Federal Trade Commission (FTC) relating to its proposed combination with Guidant.