FDAnews Device Daily Bulletin
Jan. 31, 2012 | Vol. 9 No. 21
House Democrats are urging the Committee on Energy and Commerce to hold hearings on whether the FDA and device industry are doing all they can to protect consumers from unsafe products.
Whether it’s regulatory reforms in the U.S. and Australia, new regulatory frameworks in emerging economies, regulatory guidances and harmonization activities or medtech taxes by cash-strapped governments, IMDRM spanned the globe in 2011 to bring readers useful, up-to-date information on international medical device regulations.
The Chinese Department of Health has issued a field safety notice for Terumo Cardiovascular Systems’ Terumo CDI Blood Parameter Monitoring System 500 due to a faulty contact between the power cables and the sharp edge of the chassis that can potentially damage the cables’ insulation, resulting in an electrical short.
The ombudsman’s office for the FDA’s medical device arm released details of the contacts it had with the public last year, including complaints about the watchdog agency’s reviews of medical technology.
Michael Carome, deputy director of Public Citizen’s Health Research Group and author of a petition to recall the Stryker Corporation’s Wingspan stent, boldly criticized the FDA for not recalling the medical device due to evidence of increased possibility of stroke in certain patients when the Wingspan stent was used.
Carl Zeiss Meditec has gained clearance from the U.S. Food and Drug Administration to include new dry age-related macular degeneration and glaucoma diagnostic tools in a software upgrade for the Cirrus HD-OCT.
Hugo Campos has a small computer buried in his chest to help keep him alive.
To make the electronic devices physically flexible, researchers at North Carolina State University have developed a new method for creating elastic conductors made of carbon nanotubes.
Medtronic announced the FDA approval and launch of the DF4 High-Voltage Connector System, a right ventricular lead and connector used with implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators to detect and accurately treat potentially life-threatening heart rhythms.
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