Popular Articles

CE Mark Extended For Disc Dynamics' DASCOR(R) Disc Arthroplasty System
Disc Dynamics, Inc., a leading developer of minimally invasive treatment options for low back pain caused by degenerative disc disease (DDD), announced that the CE Mark received in the European Union for its DASCOR® Disc Arthroplasty System has been expanded to incorporate a posterior-lateral surgical approach, as well as an endoscopic approach.

BSD Receives FDA Humanitarian Use Designation For The BSD-2000 Hyperthermia System
BSD Medical Corporation (NASDAQ:BSDM) announced that the U.S. Food and Drug Administration (FDA) has granted Humanitarian Use Device (HUD) designation for the company"s BSD-2000 Hyperthermia System for use in conjunction with radiation therapy for the treatment of cervical carcinoma patients who are ineligible for chemotherapy. This is the first of the two steps required to obtain Humanitarian Device Exemption (HDE) marketing approval, which requires BSD Medical to demonstrate the device"s safety and probable benefit in treating a disease or condition that affects fewer than 4,000 individuals in the United States per year. Now that FDA has granted the Humanitarian Use Designation for the BSD-2000, which confirms that the intended use population is fewer than 4,000 patients per year, BSD can file an HDE submission with the FDA. FDA has 75 days from the date of receipt of the HDE submission to grant or deny an HDE application. This period includes a 30-day filing period during which FDA determines whether the HDE application is sufficiently complete to permit substantive review. During this review, FDA may refine the indications for use which received HUD designation to finalize the indications for use for which HDE approval will be granted. This decision will be based on the data that are available to support the device"s HDE application. The company believes that the data previously submitted to FDA and reviewed by the agency in the company"s pending PMA application can be used to support the HDE approval, and that this previous review may expedite marketing approval for the BSD-2000.
News of the day
Study Shows GSK's Novel Diabetes Treatment SYNCRIA(R) (albiglutide) Improves Glucose Control And Reduces Weight
New Phase II data presented at the American Diabetes Association 69th Scientific Sessions in New Orleans show that the investigational type 2 diabetes treatment Syncria(R) (albiglutide) significantly reduced blood glucose levels and provided weight loss across weekly, biweekly and monthly dosing. Reducing blood sugar is a key part of managing type 2 diabetes, a disease that affects over 250 million people worldwide.
Public Health

Seniors Find Medicare Part D Too Complicated To Identify Lowest-Cost Plan

In the face of rising health care costs, a new study has found that older adults were less likely to identify the plan that minimized their total annual cost and were likely to mistakenly think they had chosen the lowest-cost plan. The study, funded by the Robert Wood Johnson Foundation® Investigator Awards in Health Policy Research, is currently available online, and will be published in the August 2009 issue of Health Services Research. "Many seniors are unaware that they can be saving hundreds of dollars every year by choosing a different drug plan, because there are entirely too many choices for them to navigate," said Yaniv Hanoch, Ph.D., lead author and lecturer at the University of Plymouth, School of Psychology, Plymouth, U.K. "The system should limit choice and empower its beneficiaries to make informed and cost-effective decisions about their prescription drug plan." Hanoch and colleagues took an in-depth look at the consumer behavior patterns of nearly two hundred mentally and physically healthy individuals age 18 and older, half age 65 or older. Participants were randomly assigned to choose among 3, 10, or 20 hypothetical Medicare prescription drug plans. The researchers found that - regardless of age - an increase in the number of insurance plans available reduced the likelihood of picking the plan with the lowest annual costs. Other factual questions about the plans were also more likely to be answered incorrectly when participants had more plans to choose from. While older adults were less able than younger ones to choose the plan that offered the lowest annual costs, they were also more confident that their decisions were correct. The authors recommend a few options for improving the system: offering one choice that seniors can opt in or out of (like Medicare Parts A and B); standardizing the benefit; or reducing the number of plans to 10 or less. "Making Part D easier for seniors to navigate should be part of the administration"s and Congress" efforts to reform health care," says Thomas Rice, Ph.D., co-author and professor of health services in the UCLA School of Public Health. "When it comes to Medicare Part D, research shows that seniors prefer less choice and more government intervention." Other findings, including a study published earlier this year by Hanoch and colleagues, show that a majority of adults believe that Medicare Part D is too complicated and difficult to comprehend. Most adults favor some form of simplification and support the idea of being able to purchase a plan directly from Medicare. Furthermore, changes in drug consumption and insurance formulary coverage could lead to spikes in a consumer"s out-of-pocket expenditures, sometimes by more than $1,000. Because the system is so difficult to navigate, seniors have been reluctant to switch plans during the annual open enrollment period. Notes: The study, "How Much Choice Is Too Much? The Case of the Medicare Prescription Drug Benefit" is available online at http://www3.interscience.wiley.com/journal/122407933/abstract. Additional coauthors include Janet Cummings, B.A., with the Department of Health Services, UCLA School of Public Health, Los Angeles, Calif., and Stacey Wood, Ph.D., with the Department of Psychology, Scripps College, Claremont, Calif. Natalia Barolin Investigator Awards in Health Policy Research


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