Medical
CDRH Learn Course List (Spanish)
March 28, 2010 4:21 pm | by FDA (The Center for Devices and Radiological Health) | News | CommentsCDRH has posted a Spanish language version of CDRH Learn course on Quality System Regulation, 21 CFR Part 820, Basic Introduction
Consumer Information on: Complete & #xae; SE Vascular Stent System (20-100mm lengths) - P090006
March 28, 2010 4:20 pm | by FDA (The Center for Devices and Radiological Health) | News | CommentsThe Complete SE Vascular Stent is a thin, flexible metal mesh tube that can be implanted in the large arteries that supply blood to the pelvis and legs (iliac arteries). It consists of two parts, the stent and the delivery system. The stent is an...
'Smart' Contact Lens Looks to Glaucoma Diagnosis
March 25, 2010 8:26 am | News | CommentsSTMicroelectronics will develop and supply a wireless MEMS sensor that acts as a transducer, antenna and mechanical support for additional read-out electronics in a 'smart' contact lens platform developed by Sensimed AG.
Driver Modules Power Mid-size, Multi-string, LED backlit LCDs
March 25, 2010 5:55 am | Endicott Research Group | Product Releases | CommentsThe SFDMD Series is designed for applications that require a small footprint with high efficiency and brightness stability over a wide input voltage range, such as medical patient monitors, POS, kiosk, ATM, gaming and GPS displays. Less than 5 mm high, with a footprint of 2.782” (70.66 mm) x 0.96” (24.4 mm), drivers offer
Fully Integrated Analog Front End Performs In ECG, EEG Apps
March 22, 2010 12:06 pm | Product Releases | CommentsTexas Instruments introduced the first in a family of fully integrated analog front ends (AFEs) for portable and high-end electrocardiogram (ECG) and electroencephalogram (EEG) equipment, as well as patient monitoring and consumer medical applications. The eight-channel, 24-bit ADS1298
Rotarix Vaccine: Update to Clinicians and Public Health Professionals
March 22, 2010 11:20 am | by FDA MedWatch | News | CommentsRecommendation to suspend use is a precaution while FDA learns more about the situation. No known safety risk at this time.
Zocor (simvastatin): increased risk of muscle injury with high doses
March 19, 2010 10:20 am | by FDA MedWatch | News | CommentsOngoing review shows risk also increased when drug, especially at higher doses, is used with certain drugs.
Boston Scientific Implantable Cardioverter Defibrillators: Recall
March 19, 2010 10:20 am | by FDA MedWatch | News | CommentsPractitioners should not use these devices unless and until FDA reviews and approves changes made by the manufacturer.
Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall
March 18, 2010 10:20 am | by FDA MedWatch | News | CommentsDefective devices may result in air bubbles leaking into the infusion system and into the patient’s bloodstream.
Cleviprex (clevidipine butyrate): Recall
March 17, 2010 3:20 pm | by FDA MedWatch | News | CommentsThe recall of 12/2009 has been expanded to include four additional lots. Presence of particulate matter which could potentially reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions.
Power Rocker Switch is Water Resistant
March 17, 2010 6:46 am | Product Releases | CommentsPhaseda LLC has introduced a water resistant power rocker switch. This HB-series rocker switch has a special internal design that leads water away from the contacts, making it appropriate for
Teleflex Arrow IV Tubing Sets, Accessories, and Embolectomy Catheters: Recall
March 16, 2010 5:20 am | by FDA MedWatch | News | CommentsProduct sterility cannot be guaranteed. Testing revealed pin holes in some of the pouches in which the products are packaged.
Plavix (clopidogrel): Reduced effectiveness in patients who are poor metabolizers of the drug
March 12, 2010 11:20 am | by FDA MedWatch | News | CommentsBoxed warning added regarding reduced effectiveness of Plavix in poor metabolizers.
Counterfeit Polypropylene Surgical Mesh: Initial Communication
March 12, 2010 9:20 am | by FDA MedWatch | News | CommentsVarious sizes of counterfeit flat sheets of polypropylene surgical mesh are being marketed in the United States labeled with the C. R. Bard/Davol brand name.
Baylis Medical Company Torflex Transseptal Guiding Sheath: Class I Recall
March 11, 2010 11:20 am | by FDA MedWatch | News | CommentsSheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.
Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures
March 11, 2010 7:20 am | by FDA MedWatch | News | CommentsFDA review of available data have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.
Beckman Coulter UniCel DxC Synchron Clinical System – Ion Selective Electrode Flow Cell: Class I Recall
March 11, 2010 5:20 am | by FDA MedWatch | News | CommentsIncorrect sodium results may be caused by build-up of protein, bacteria, and sample tube additives in the ion selective electrode flow cell.
DAC Helps Enable Clear Diagnostic Images
March 10, 2010 2:32 pm | Analog Devices, Inc. | Product Releases | CommentsAnalog Device’s AD5791 high-accuracy 20-bit digital-to-analog converter (DAC) is said to be the industry’s first to feature true 1-ppm (parts per million) resolution and accuracy, provides four times greater accuracy and four times more resolution than competing converters. The AD5791 features
Abiomed AB5000 Circulatory Support System: Class I Recall
March 10, 2010 12:20 pm | by FDA MedWatch | News | CommentsDevice computer may shut down without an alarm, which can lead to serious injuries or death.
WinRho SDF (Rho(D) Immune Globulin Intravenous (Human): Risk of Intravascular Hemolysis
March 10, 2010 8:20 am | by FDA MedWatch | News | CommentsCases of intravascular hemolysis and its complications have been reported in patients treated for immune thrombocytopenic purpura with WinRho.
Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife, NK, Responder models): Class I Recall
March 8, 2010 10:20 am | by FDA MedWatch | News | CommentsUPDATED 03/08/2010: Recall classified as Class I, expanded list of affected models. Originally posted 02/09/2010
Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall
March 5, 2010 8:21 am | by FDA MedWatch | News | CommentsSheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.
Compact Enclosures Suit a Wide Range of Applications
March 5, 2010 6:42 am | Product Releases | CommentsElma Electronic Inc. offers a family of modular enclosures in a compact size. The MiniBox 34 serves a wide range of applications including medical, communications, industrial, test and measurement, military/aerospace, and other markets. Its construction allows
Discrete Components Optimize Medical Equipment Performance and Reliability
March 4, 2010 10:16 am | by Steve Wade, VP of Sales and Marketing, TT electronics | Articles | CommentsMedical electronics applications require components that are smaller, more robust, and highly versatile, particularly as medical equipment becomes increasingly portable. Because medical systems often use discrete electronic components in their circuit designs, passive components are critical to optimizing performance and reliability.
Y-Flash to Improve Memory Size
March 4, 2010 5:35 am | Product Releases | CommentsTowerJazz announced its patented Y-Flash technology, not available from any other foundry in the industry, which is designed to give customers flexibility on memory size, allowing optimization of performance/cost for any given application.
