Medical
Federal Register: Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
February 18, 2010 9:41 am | by FDA (The Center for Devices and Radiological Health) | News | CommentsOn March 18, 2010, the committee will discuss, make recommendations, and vote on the premarket approval application (PMA) for the Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) sponsored by Boston Scientific.
Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication
February 18, 2010 9:40 am | by FDA MedWatch | News | CommentsFDA requires REMS that ensures that only those hospitals and healthcare professionals who have enrolled and completed training in risk management program will prescribe and dispense ESAs to patients with cancer.
Maalox Total Relief and Maalox Liquid Products: Medication Use Errors
February 18, 2010 9:40 am | by FDA MedWatch | News | CommentsConsumers who have a history of gastrointestinal ulcers or a bleeding disorder should not use Maalox Total Relief because it contains bismuth subsalicylate, a substance chemically related to aspirin.
Exjade (deferasirox): Boxed Warning
February 18, 2010 9:40 am | by FDA MedWatch | News | CommentsChanges to Prescribing Information re: risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage.
Ultrasound Pulse Controller Touts High Integration
February 12, 2010 8:57 am | Stmicroelectronics | Product Releases | CommentsSTMicroelectronics has introduced an integrated low-noise ultrasound pulse controller. Built using the company’s high-voltage BCD mixed-signal technology, the STHV748 provides four independent channels, each of which generates
Illuminated Pushbutton Switch Offers Custom Cap Options
February 11, 2010 5:10 am | Product Releases | CommentsE-Switch introduced the LP15 series illuminated pushbutton switch, featuring multiple LED colors, custom marking options for the caps, and several cap sizes. The LED colors available are red, blue, green, yellow, and white. Four different
Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall
February 9, 2010 3:51 pm | by FDA MedWatch | News | CommentsDevice may not be able to deliver therapy during a cardiac resuscitation attempt.
BD Q-Syte Luer Access Devices: Recall
February 9, 2010 3:51 pm | by FDA MedWatch | News | CommentsDevice may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death.
New Low-Power Heart Sensor Produced
February 9, 2010 9:30 am | Product Releases | CommentsAt today’s International Solid State Circuit Conference, imec and Holst Centre report an analog-signal processor ASIC (application-specific integrated circuit) – in short ASP - that reduces the overall power consumption of an ambulatory heart activity signal monitoring systems by more than 5 times. This is a major step towards autonomous wireless sensor systems powered, which constantly monitor the patient’s health for diagnosis or chronic illness.
Scientists find gene variant link to aging cells
February 9, 2010 8:32 am | News | CommentsScientists have found specific genetic variants which may explain why some people age earlier than others and say their findings have important implications for understanding cancer and age-related diseases. Dutch and British researchers analyzed more than 500,000 genetic variations from human gene maps and found that people with particular variants near a gene called TERC were likely to be biologically older by 3 to 4 years.
Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Postmarket Surveillance
February 8, 2010 9:51 am | by FDA (The Center for Devices and Radiological Health) | News | CommentsThe FDA is announcing an opportunity for public comment on the proposed collection of certain information by the agency.
Tysabri (Natalizumab): Update of Healthcare Professional Information
February 5, 2010 7:51 am | by FDA MedWatch | News | CommentsRisk of developing progressive multifocal leukoencephalopathy (PML) increases with increasing duration of exposure to Tysabri.
Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical
February 4, 2010 12:51 pm | by FDA MedWatch | News | CommentsSheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death.
Thomas Medical Products Initiates Worldwide Recall Of Safesheath® CSG® Sheath Introducer
February 3, 2010 11:52 pm | by General Electric | News | CommentsSOURCE
GE Healthcare Expands Portfolio of ecomagination Products
February 3, 2010 11:52 pm | by General Electric | News | CommentsNewly approved ecomagination products help hospitals reduce costs and waste, delivering positive benefits to the environment
GE Healthcare showcases innovations and healthymagination at the SMFM 30th Annual Meeting
February 3, 2010 11:51 pm | by General Electric | News | CommentsVoluson E8, Voluson i and ViewPoint highlight company focus on women’s healthcare
Federal Register: Strengthening the Center for Devices and Radiological Health's 510(k) Review Process; Public Meeting; Request for Comments
February 3, 2010 11:51 pm | by FDA (The Center for Devices and Radiological Health) | News | CommentsThe purpose of the public meeting is to identify actions that CDRH can consider taking to strengthen the premarket notification process for review of medical devices, also known as the 510(k) process. FDA is seeking input on a number of identified...
Federal Register: The Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
February 3, 2010 11:51 pm | by FDA (The Center for Devices and Radiological Health) | News | CommentsOn March 12, 2010, the committee will discuss, make recommendations, and vote on a premarket approval application for the Deep Brain Stimulation System for Epilepsy sponsored by Medtronic, Inc.
Federal Register: Workshop on Pediatric Neurological and Neurocognitive Assessments for Cardiovascular Devices; Public Workshop
February 3, 2010 11:51 pm | by FDA (The Center for Devices and Radiological Health) | News | CommentsThe purpose of the public workshop is to solicit information from clinicians, academia, professional societies, other government agencies, and industry on various neurological and neurocognitive assessments for pediatric patients implanted with...
Infrared Emitter Includes Built-in Drive Electronics
February 3, 2010 1:49 pm | Product Releases | CommentsCal Sensors announced the launch of PIREPlus, a high-output, high-pulse rate emitter that can be pulsed as a source of blackbody radiation for near-to-far infrared applications at 180 Hz with 50 percent modulation depth. With a pulsing speed that is asserted to be 18 times faster than alternative technologies, the emitter
External Switching Power Supplies are Factory-configurable
February 2, 2010 12:52 pm | Product Releases | CommentsBEAR Power Supplies has introduced its BE Series external AC/DC power adapters. The units are Energy Star qualified and factory-configurable for commercial, industrial and medical instruments. The BE Series includes wall-mount converters from 5 W to 30 W, and desktop converters from 15 W to 60 W. All have
Blind Mateable Connectors Can be Cleaned More Than 2500 Times
February 1, 2010 4:59 am | Product Releases | CommentsITT Interconnect Solutions has expanded its family of sealed, miniature, lightweight connectors for modern and "future soldier" applications with a "Super Clean" version. Also suitable for medical use, the Nemesis SC connectors are
Zyprexa (olanzapine): Use in Adolescents
January 29, 2010 7:51 pm | by FDA MedWatch | News | CommentsClinicians should consider the potential long-term risks when prescribing to adolescents.
Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension
January 29, 2010 11:51 am | by FDA MedWatch | News | CommentsRisk information added to Warnings/Precautions section and data summary provided
Resistor Networks Are Configured in Isolated and Bussed Circuits
January 29, 2010 6:14 am | Product Releases | CommentsTT electronics BI Technologies has developed two SON (aka QFN or DFN) eight-pad packaged sample kits. Designated SFN08AKIT and SFN08BKIT, the sample kits include four or seven ultra-stable thin film resistors configured in isolated and bussed circuits, respectively. Each sample kit contains
