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Fresenius Medical Care AG & Co. KGaA, the world's largest provider of dialysis products and services, is one of the few German companies to voluntarily adopt new U.S. regulations early and assessed the Company's internal control over financial reporting as effective.
The new guidelines for import and manufacture of medical devices notified by the Ministry of Health and Family Welfare would affect the medical devices manufacturing sector in Indian, the Confederation of Indian Industry (CII) said.
The Department of Health (DOH) on Thursday announced it was making life significantly easier for companies wanting to register and sell medical devices in Taiwan.
A new test that combines multiple scientific disciplines can predict accurately which men are either at high or low risk for a return of
cancer after surgical removal of the prostate gland.
GE Healthcare today announced it has received clearance from the U.S. Food and Drug Administration for the company's new wide bore computed tomography (CT) system.
Medtronic, Inc. today announced that it has received CE Mark (Conformité Européene) approval for its next-generation self-expanding carotid stent and filter system, providing patients afflicted by carotid artery disease with a new, minimally-invasive treatment option to surgical procedures for the prevention of stroke.
The FDA has issued guidance on updated labeling requirements for single-use devices to comply with the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), which was amended in 2005.
The FDA has issued guidance for industry and FDA staff on device postmarket surveillance (PS), which consolidates three separate documents into a single, comprehensive document.
The medical device industry must consider its role in cost containment and cost-effectiveness in the overall U.S. healthcare picture, argued experts at the recent World Healthcare
Congress in Washington, D.C.
Imaging3, Inc., developer of a breakthrough medical imaging device that produces 3D medical diagnostic images of virtually any part of the human body in real-time, today provided insight into one of the many health care sectors where its new product, The Dominion is poised to usher in a revolutionary shift of the health care paradigm.