Health Highlights: Feb. 8, 2011
FDA Speeds Approval Process for Some Medical Devices Chromosome Fault Linked to Sleepwalking: Study Safety Restrictions Added to Avandia Labeling
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
FDA Speeds Approval Process for Some Medical Devices
A prosthetic arm will be the first product assessed under a new system meant to speed up approval of innovative medical devices that could dramatically improve patients' lives, says the U.S. Food and Drug Administration.
The FDA's Innovation Pathway program aims to review first-of-a-kind devices in five months, which is about half the time it currently takes, the Associated Press reported.
An accelerated FDA approval program for drugs has been in place since 1992, but medical device manufacturers have long complained that the agency's review time for their products is far longer than in other countries.
The United States is the seventh slowest nation in terms of device approvals, according to medical device executives who took part in a PricewaterhouseCoopers survey released last month, the AP reported.
Companies accepted into the new program will receive a written agreement with a target approval date and an outline of the review process, the FDA said. A special in-house committee of experienced managers and scientists will conduct the reviews.
The FDA will hold a public meeting March 15 to gather public comments about the new program, the AP reported.
The prosthetic arm being reviewed was developed by the U.S. Department of Defense. The arm is remotely connected to a microchip in the brain that's said to enable near-natural coordination of the artificial hand and fingers. The device is designed for people who have suffered spinal cord injury, amputation or stroke.
Chromosome Fault Linked to Sleepwalking: Study
A genetic link to sleepwalking has been identified by researchers.
They studied four generations of a family of sleepwalkers and concluded that the condition is associated with a fault in a section of chromosome 20, BBC News reported.
Just one copy of the defective DNA is enough to cause sleepwalking, according to Dr. Christina Gurnett and colleagues at the Washington University School of Medicine.
The next step is to identify the specific gene(s) in sleepwalking. That could lead to new treatments for the condition that affects up to 10 percent of children and two percent of adults, BBC News reported.
The study was published in the journal Neurology.
Safety Restrictions Added to Avandia Labeling
Labeling of the diabetes pill Avandia has been updated to include safety restrictions ordered by the U.S. Food and Drug Administration, says drug maker GlaxoSmithKline.
The FDA ordered the action because of Avandia's link to heart attack, the Associated Press reported. The updated labeling says the drug is only intended for diabetes patients whose blood sugar cannot be controlled with any of the other available diabetes drugs.
Avandia, which was approved by the FDA in 1999, became the top-selling diabetes drug in the world by 2006. But it's use has sharply dropped since a 2007 analysis linked it to heart attack.
Avandia has been banned in Europe and is the subject of thousands of lawsuits and a Department of Justice investigation, the AP reported.