Shares of Antares Pharma and Boston Scientific on the Upswing -- Medical Equipment and Supplies Industry Soaring in 2012
March 06 2012 - 7:20AM
Marketwired
The Medical Equipment and Supplies Industry has performed well this
year. The iShares Dow Jones U.S. Medical Devices Index Fund (IHI)
-- which seeks to replicate a measurement of the performance of the
medical equipment sector of the United States equity market, and
includes medical equipment companies, such as manufacturers and
distributors of medical devices, such as magnetic resonance imaging
(MRI) scanners, prosthetics, pacemakers, x-ray machines, and other
non-disposable medical devices -- is up in excess of 10 percent
already in 2012. Five Star Equities examines the outlook for
companies in the Medical Equipment & Supplies industry and
provides equity research on Antares Pharma Inc. (NYSE Amex: AIS)
and Boston Scientific Corporation (NYSE: BSX). Access to the full
company reports can be found at:
www.fivestarequities.com/AIS
www.fivestarequities.com/BSX
After years of lax regulation, the FDA's top medical-device
regulator said the agency needs more power to block unsafe
products. According to Bloomberg, the debate centers on the
agency's 510(k) program, which is used to clear 90 percent of
medical products in the U.S. each year. The process can allow
devices on the market without human testing if the FDA deems them
"substantially equivalent" to previously approved versions, known
as predicates. Changing the law "will bolster the strength of the
510(k) program, which repeatedly comes under criticism, and
oftentimes, it's for just a handful of cases," Jeffry Shuren
director of the FDA's Center for Devices and Radiological Health
says.
Five Star Equities releases regular market updates on the
Medical Equipment & Supplies industry so investors can stay
ahead of the crowd and make the best investment decisions to
maximize their returns. Take a few minutes to register with us free
at www.fivestarequities.com and get exclusive access to our
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In 2008, the U.S. Supreme Court gave manufacturers immunity from
lawsuits for any medical device that received "pre-market approval"
from the Food and Drug Administration (FDA). Now, Congress is
considering restoring some legal rights. The House Energy and
Commerce Health Subcommittee hearing met last month to discuss the
Medical Device User Fee Act (MDUFA), which was sent to Congress in
February. It represents an agreement reached by the FDA and the
device industry and would more than double the current user fee
level of $287 million. Under the MDUFA proposal, a device company
would have to pay about $220,000 to have its high-risk device
reviewed under the FDA's premarket review process.
Jeffery Shuren told congress that doubling of user fees
collected from device makers will improve the efficiency of FDA
approvals.
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