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
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
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
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
BBC News reported.
The study was published in the journal
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
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
Avandia has been banned in Europe and is the subject of
thousands of lawsuits and a Department of Justice investigation,
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