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Articles from 2006 In July


FTC Warns Public about Home Genetic Tests

In particular, the commission says, people should be wary of claims of measuring the risk of developing a particular disease and the likelihood of being able to withstand environmental exposures. While it is probably not fair to characterize all such products as snake oil, it is also prudent to put the results from these tests in their proper context. That means consulting your doctor.

CMS Gets the Message on Reimbursement Policy

The Hill reports that at least 245 members of Congress have signed letters requesting that CMS delay implementation of the changes, in addition to similar requests to CMS made by AdvaMed and MDMA. CMS administrator Mark McClellan said he had heard the complaints loud and clear, and that he had taken them to heart. Since the final version of the regulation could be issued as soon as next Tuesday, industry may soon see whether he really did.

Could Stents Replace Prozac?

Those with a high level of carotid stenosis (greater than 80%) exhibited substantial depressive symptoms compared with controls. Another 33.6% of the patients with carotid stenosis had depressive symptoms, compared with 16.7% of the control patients. Four weeks after carotid stenting, only 9.8% of the patients with carotid stenosis exhibited depressive symptoms. Mlekusch believes that stenting had an advantage over other surgical treatment for stenosis. He cautions that carotid stenting may be able to reduce symptoms associated with vascular depression, but it is not a cure or treatment for major depression.

CAM Software Firm Unveils Redesigned Site

E-NEWS

CAM Software Firm Unveils Redesigned Site

A developer of computer-aided manufacturing (CAM) software for CNC machine tools has given its Web site a facelift. In addition to the redesign, Gibbs and Associates (Moorpark, CA) has introduced a host of information relating to its GibbsCAM product family, presented in a user-friendly format. The site provides users with an overview of the software, as well as reasons to select it over competitors. Plus, applications are discussed in detail, along with corresponding screen shots of the software. Data sheets and success stories are also available. The company has retained some of its former popular features, including its customer service online support, according to the firm. This section of the site features downloadable maintenance updates and utilities, as well as the company’s support center. Another tool for users is the company-hosted message board, which encourages discussion of industry topics.
Copyright ©2006 Medical Product Manufacturing News

Testing Laboratory Seeks to Educate Customers  

E-NEWS

Testing Laboratory Seeks to Educate Customers

www.testedandproven.com
In an effort to keep customers informed of industry news and standards, a package-, part-, and material-testing lab has launched a new site. The DDL (Eden Prairie, MN) site outlines the company’s testing capabilities and validation services. Among those capabilities are the testing of medical devices and their packaging. Because of its ties to medical packaging testing, the company will host three Webinars devoted to changes in the ISO 11607 standard on packaging for terminally sterilized medical devices. Furthermore, the site provides an industry search tool yielding standards for which the company tests packaging and products for compliance. Users can also request relevant industry-related articles from the site.
Copyright ©2006 Medical Product Manufacturing News

Company Restructuring Prompts New Site

E-NEWS

Company Restructuring Prompts New Site

www.adhesivesresearch.com
An adhesives company has developed a new Web site in order to reflect its reorganization into four operating divisions. The site addresses the functions and capabilities of the ARcare, ARclad, ARx, and ARmark divisions. Designed for ease of use for customers worldwide, the Adhesives Research (Glen Rock, PA) home page presents visitors with the option of entering the North America, Europe, or Asia portal. Each portal includes customized contact information and corporate descriptions. Among the improved features are product data sheets that are available in PDF format. Visitors can print the product pages or e-mail them to a friend. In addition, a keyword search helps users find desired information quickly.
Copyright ©2006 Medical Product Manufacturing News

Enclosure Manufacturer Debuts Web Site

E-NEWS

Enclosure Manufacturer Debuts Web Site

www.hoffmanonline.com
As a result of research, feedback, and an analysis of esteemed business-to-business sites, an enclosure company has redesigned its Web site. The main motivation behind the redesign of the Hoffman (Anoka, MN) Web site was to improve navigation, according to the firm. To achieve the desired effect, the company equipped the site with the option to locate information via product, service, or industry categories through the navigation bar. Meanwhile, a universal search function enables visitors to find products by catalog or model number, or by keyword from any page on the site. An advanced product search permits users to enter in such information as size requirements and type of material.
Copyright ©2006 Medical Product Manufacturing News

Big Week for FDA Approvals

unit received approval for a contraceptive rod that can prevent pregnancy for up to three years. The Implanon works by releasing a slow stream of progestin. Abbott has won the right to market the first fully automated confirmatory and screening test for Hepatitis B Surface Antigen. It will be used to test those donating blood, blood components, and organs. And St. Jude Medical got approval for two defibrillators, branded under the Atlas II name, geared to patients whose hearts are especially hard to defibrillate. One is an implantable cardioverter-defibrillator and the other is a cardiac resynchronization therapy defibrillator. Isn't it nice to see the agency so productive?

Ultrasonic Laser Could Be Used for Diagnostics

EMERGING TECHNOLOGIES

Ultrasonic Laser Could Be Used for Diagnostics


An ultrasound analog version of a laser could one day be used for medical diagnostics. Researchers at the University of Missouri–Rolla and the University of Illinois at Urbana-Champaign developed the device.

Called a uaser— for ultrasound amplification by stimulated emission of radiation— the instrument produces ultrasonic waves that are coherent and of one frequency, and could be used to study laser dynamics and detect subtle changes, such as phase changes, in modern materials.

“We have demonstrated that the essential nature of a laser can be mimicked by classical mechanics—not quantum mechanics—in sound instead of light,” said Richard Weaver, a professor of theoretical and applied mechanics at the University of Illinois.

The uaser was made by mounting a number of piezoelectric autooscillators to a block of aluminum, which serves as an elastic, acoustic body. When an external acoustic source is applied to the body, the oscillators synchronize to its tone. The oscillators synchronize to the frequency of the source.

In the absence of an external source, the tiny ultrasonic transducers become locked to one another by virtue of their mutual access to the same acoustic system.

“The phases must be correct also,” says Weaver. “By carefully designing the transducers, we can assure the correct phases and produce stimulated emission. As a result, the power output scales with the square of the number of oscillators.”

The uaser more closely resembles a “random laser” than it does a conventional, highly directional laser, Weaver said. “In principle, however, there is no reason why we shouldn’t be able to design a uaser to generate a narrow, highly directional beam.”

Copyright ©2006 Medical Product Manufacturing News

Medtronic Settles Kickback Charges for $40 Million

The Justice Department said the kickbacks took the form of âEURoesham consulting agreements, sham royalty agreements, and lavish trips to desirable locations." Medtronic has agreed to create a database that tracks transactions not related to device sales, and to have the data reviewed by internal and external panels. Sounds like something other firms should be doing, too.