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Heparin: Change in Reference Standard

April 7, 2010 8:20 am | by FDA MedWatch | News | Comments

New studies reinforce FDA’s previous recommendation for healthcare professionals to exercise clinical judgment in determining the dose of heparin for a patient.

Stud Capsule For Men: Product contains Undeclared Drug Ingredient

April 6, 2010 7:20 pm | by FDA MedWatch | News | Comments

Product adulterated with sildenafil which may interact with nitrates to lower blood pressure to dangerous levels.

Infographics of 2009 Patent Activity

April 2, 2010 6:05 am | News | Comments

Here are some graphics that display overall patent activity in semiconductors and medical devices by technology area in 2009.

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Stalevo (entacapone/carbidopa/levodopa): Ongoing Safety Review

March 31, 2010 11:20 am | by FDA MedWatch | News | Comments

FDA is evaluating clinical trial data that may suggest that patients taking Stalevo may be at an increased risk for developing prostate cancer.

Designing a Wireless Heart Rate Monitor with Remote Data Logging

March 31, 2010 5:59 am | by Archana Yarlagadda, Applications Engineer, Cypress Semiconductor | Articles | Comments

Extending the Human-to-Machine Interface (HMI) using wireless communications is a fast developing field. Important improvements in HMI functionality have been made possible by continuing advancements in Machine-to-Machine interfaces in terms of increased baud rate, low power consumption and reach (distance) of communication.

Pin Fin Heat Sinks: A Sharper Way to Keep Medical Electronics Cool

March 31, 2010 5:42 am | by Barry Dagan, Cool Innovations, www.coolinnovations.com | Articles | Comments

Electronic medical systems have become substantially more sophisticated and powerful in recent years. As a result, the majority of these systems contain large arrays of power hungry electronic components that require high-performance heat sinks to prevent them from overheating and being damaged or destroyed.

Simplify USB Isolation in Medical Applications

March 31, 2010 5:10 am | by Mark Cantrell, Analog Devices, Inc., www.analog.com | Articles | Comments

The personal computer (PC), currently the standard information-processing device for office and home use, communicates with most peripherals using the universal serial bus (USB). Standardization, cost, and the availability of software and development tools have made the PC very attractive as a host-processor platform for medical and industrial applications...

Nano-discs destroy cancer cells

March 30, 2010 5:29 pm | by ArgonneNationalLab | Videos | Comments

A new technique, designed with the potential to treat brain cancers, is under study at Argonne National Laboratory and the University of Chicago Medical Center. The micron-sized magnetic materials, with vortex-like arrangements of spins, were successfully interfaced with Glioblastoma...

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MasXtreme Capsules (Natural Wellness) - product contains undeclared drug ingredient

March 30, 2010 3:20 pm | by FDA MedWatch | News | Comments

Recall of product, sold as a dietary supplement, containing undeclared aildenafil as well as the drug phentolamine.

U of M Researcher discovers how electricity moves through cells

March 30, 2010 8:50 am | News | Comments

Researchers at the University of Minnesota have created a molecular image of a system that moves electrons between proteins in cells.

Consumer Information on: Express & #xae; LD Iliac Premounted Stent System - P090003

March 28, 2010 4:22 pm | by FDA (The Center for Devices and Radiological Health) | News | Comments

The Express® LD Iliac Stent is an expandable, mesh-like stainless steel tube. The stent is mounted over a deflated balloon attached to the end of a long thin flexible tube called a stent delivery catheter...

CDRH Learn Course List (Spanish)

March 28, 2010 4:21 pm | by FDA (The Center for Devices and Radiological Health) | News | Comments

CDRH 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 | Comments

The 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...

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'Smart' Contact Lens Looks to Glaucoma Diagnosis

March 25, 2010 8:26 am | News | Comments

STMicroelectronics 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 | Comments

The 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 | Comments

Texas 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 | Comments

Recommendation 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 | Comments

Ongoing 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 | Comments

Practitioners 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 | Comments

Defective 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 | Comments

The 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 | Comments

Phaseda 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 | Comments

Product 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 | Comments

Boxed 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 | Comments

Various 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.

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