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IMAPS Gives Details of MicroTech Conference

February 23, 2010 9:10 am | News | Comments

The International Microelectronics And Packaging Society is pleased to announce details of the forthcoming MicroTech-2010 Conference featuring “Disruptive Technologies” APM featuring “Advanced Polymer, Organic & Inorganic Materials” being held at the well known Cambridge University Møller Centre. The location is ideally placed near many of the forward thrusting new and established companies as well as at a great historic city.

Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety

February 22, 2010 12:20 pm | by FDA MedWatch | News | Comments

FDA is reviewing data from a large, long-term clinical study on possible risks for cardiovascular outcomes associated with use of rosiglitazone.

Ear Candles: Risk of Serious Injuries

February 20, 2010 12:20 pm | by FDA MedWatch | News | Comments

Consumers warned not to use ear candles because they can cause serious injuries, even when used according to the manufacturer’s directions.

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Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements

February 19, 2010 8:20 am | by FDA MedWatch | News | Comments

FDA requires risk management plan and class-labeling changes for all LABAs.

Federal Register: Agency Information Collection Activities; Submission for OMB Review; Comment Request; Guidance for Humanitarian Device Exemption Holders, Institutional Revie...

February 18, 2010 9:41 am | by FDA (The Center for Devices and Radiological Health) | News | Comments

The FDA is announcing that a proposed collection of information has been submitted to the OMB for review and clearance under the Paperwork Reduction Act of 1995.

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 | Comments

On 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 | Comments

FDA 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 | Comments

Consumers 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.

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Exjade (deferasirox): Boxed Warning

February 18, 2010 9:40 am | by FDA MedWatch | News | Comments

Changes 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 | Comments

STMicroelectronics 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 | Comments

E-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 | Comments

Device 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 | Comments

Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death.

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New Low-Power Heart Sensor Produced

February 9, 2010 9:30 am | Product Releases | Comments

At 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 | Comments

Scientists 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 | Comments

The 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 | Comments

Risk 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 | Comments

Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death.

GE Healthcare Expands Portfolio of ecomagination Products

February 3, 2010 11:52 pm | by General Electric | News | Comments

Newly 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 | Comments

Voluson 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 | Comments

The 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 | Comments

On 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 | Comments

The 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 | Comments

Cal 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 

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