Miscellaneous
• Life with Lars Leksell on page 8, written from the perspective of his son, Dan Leksell, Executive Vice President and Senior Advisor at Elekta, provides insight into the history of the company and the man who built it.
• See how a 17-year-old cancer survivor becomes an advocate for teens across the globe – her heartfelt story on page 24.
• On page 34, learn more about the benefits three centers have experienced using MOSAIQ® – Elekta’s EMR solution that’s set the bar by which all other radiation and medical oncology information systems are measured.
• On page 40, we go behind the scene for a glimpse of the development of Elekta’s new Monaco® treatment planning system with VMAT as well as the group behind its development.
Enjoy this issue of Wavelength!
Wavelength
Dr. Donald L. Trump, President and CEO of Roswell Park Cancer Institute (RPCI), America’s first cancer center, will have his head shaved by a Roswell Park cancer patient on March 3, 2010 to honor the Institute’s 26,292 patients, and to encourage others to participate in the “Goin’ Bald for Bucks” program.
Dr. Trump has dedicated his career to the fight against cancer. On March 3, at 10 am at Roswell Park, he’ll make a different, and very visible, contribution to the cause when he shaves his mustache—a fixture on his face since medical school—and his entire head.
RPCI is recognized by the National Cancer Institute (NCI) as one of only 40 Comprehensive Cancer Centers in the United States. The institute is also one of 21 members of the prestigious National Comprehensive Cancer Network (NCCN).
“On the surface, my challenge is based in fun. But the cause behind it means so much more,” said Dr. Trump. “I am doing this to honor the memory of my parents, who both died from cancer; to recognize the many students and others across our community and country who are setting a positive example through their “Goin’ Bald for Bucks” participation; and to pay tribute to every patient Roswell Park has the privilege of caring for.”
Dr. Trump has significant experience with the clinical aspects of vitamin D in the treatment of solid tumors and has performed more cancer clinical trials with vitamin D than anyone else in the world. He also holds both US and European patents for the use of vitamin D in cancer treatment.
Roswell Park Cancer Institute, founded in 1898, is the nation’s first cancer research, treatment and education center, and currently serves patients from across America and the world. The Institute was one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York.
Since 2002, “Goin’ Bald for Bucks” has raised more than $700,000 for Roswell Park Cancer Institute, thanks to the many schools, organizations and individuals that have raised pledges and given up their locks for the cause. It was founded at Lake Shore High School in a suburb of Buffalo, NY, to support the sister of teacher Tony George during her cancer battle.
Donations to Dr. Trump or any Goin Bald for Bucks participant are now being accepted at www.bald4bucks.org or by phone at 716-845-8788. Individuals, companies and schools are also encouraged to register for the program.
Elekta has launched a new corporate Web site that provides healthcare professionals, patients, investors and the public with new ways to interact, navigate and browse information about Elekta’s solutions for treating cancer and brain disorders.
New Look for Elekta.com
Designed with the customer in mind, Elekta.com offers increased functionality, including a new, clean design that appeals to a global audience. The site’s architecture, search ability and navigation also were enhanced, allowing easy and intuitive navigation between product pages, case studies, streaming video clips, financial reports and more. With greater optimization for search engines, content sharing with social media sites –
such as Twitter, Facebook and LinkedIn – is more straightforward.
“When redesigning Elekta.com, our objective was to make it easy for anyone who visits to understand who we are and what our vision is for cancer care,” says Mark Arnold, Vice President of Global Marketing for Elekta. “Second, we want users to have the ability to pinpoint the information and resources they need with minimal clicks.”
To make it faster and easier to find information, Elekta also combined content from Elekta Impac Software and Elekta CMS Software into the new Elekta.com. Elekta acquired Impac Medical Systems in 2005 and Computerized Medical Systems in 2008.
New Look for Elekta.com
“With the new site, we wanted to provide access to our entire portfolio of products all through a single entry point,” Arnold says. “For this initial launch phase, the peripheral Web sites will remain up and running for a limited period to gradually prepare our users for the implementation of a single Web site for all companies.”
To further refine customer experience, additional updates to Elekta.com will follow throughout the next six months.
FDA Seal
This is known as Premarket Notification – also called PMN or 510(k) . It allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, “new” devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.
Any device that reaches market via a 510(k) notification must be “substantially equivalent” to a device on the market prior to May 28, 1976 (a “predicate device”). If a device being submitted is significantly different, relative to a pre-1976 device, in terms of design, material, chemical composition, energy source, manufacturing process, or intended use, the device nominally must go through a pre-market approval, or PMA. This does not always happen.
As of 2007, this has been implemented by splitting devices into three classes:
• Class I: Devices that do not require premarket approval or clearance but must follow general controls. Dental floss is a class I device.
• Class II: Devices that are cleared using the 510(k) process. Diagnostic tests, cardiac catheters, and amalgam alloys used to fill cavities are all class II devices. The “predicate device” in question is often quite different, and this process is largely used to clear devices for marketing which do not meet the criteria to be considered class III. Hearing aids are class II devices.
• Class III: Devices that are approved by the Premarket Approval (PMA) process, analogous to a New Drug Application. These tend to be devices that are permanently implanted into a human body or may be necessary to sustain life. An artificial heart meets both criteria. The most commonly recognized class III device is an Automated External Defibrillator. Devices that do not meet either criteria are generally cleared as class II devices.
A device that reaches market via the 510(k) process is not considered to be “approved” by the FDA. Nevertheless, it can be marketed and sold in the United States. They are generally referred to as “cleared” or “510(k) cleared” devices.
George Andl, Bee Keeper
PBA Atlanta
George also has his own blog dedicated to Bee Keeping: Bee Surprised Blog
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