MAKO Surgical and Hansen Medical Making Headway With Their Products
November 11 2011 - 8:16AM
Marketwired
With profit margins for medical equipment and supply manufacturers
already being squeezed via sweeping healthcare reform, companies in
the sector could face more headwinds in the future as industry
experts have begun questioning the FDAs approval process. The
Bedford Report examines investing opportunities in the Medical
Equipment & Supplies industry and provides equity research on
MAKO Surgical Corporation (NASDAQ: MAKO) and Hansen Medical, Inc.
(NASDAQ: HNSN). Access to the full company reports can be found at:
www.bedfordreport.com/MAKO
www.bedfordreport.com/HNSN
Over the summer, The Institute of Medicine recommended that the
US government create a new system of approving medical devices
because the current system does not guarantee the products are
safe. The panel from the Institute for Medicines also said the FDA
should abandon a process that allows for medical devices to be
approved if the manufacturers prove they are similar to devices
that are already on the market. Currently, the FDA approves medical
devices without human studies if it is "substantially equivalent"
to other devices that were previously cleared or that were on the
market before 1975.
The Bedford Report releases stock reports on the Medical
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The FDA says it disagrees with the recommendations and wants to
amend its current process, not overhaul it. The current oversight
system has been simultaneously faulted for inadequate assurance of
safety and efficacy and for suppressing innovation. Since
regulatory approval is dependent on claims of similarity to
previously approved devices, the process can encourage the
development of devices that provide only small improvements at
higher cost than their predecessors.
MAKO Surgical Corporation is a medical device company that
markets its advanced robotic arm solution and orthopedic implants
for orthopedic procedures. The Company offers MAKOplasty, a
restorative surgical solution that enables orthopedic surgeons to
treat patient specific, osteoarthritic disease. Recently the
company announced the introduction of MAKOplasty Total Hip
Arthroplasty, a total hip-replacement procedure that uses the
company's RIO Robotic Arm Interactive Orthopedic System, which was
approved by the FDA last year.
Hansen Medical products and technology using robotics for the
accurate positioning, manipulation and control of catheters and
catheter-based technologies. The Company's Sensei X Robotic
Catheter System and Artisan Control Catheter were cleared by the
U.S. Food and Drug Administration for manipulation and control of
certain mapping catheters in electrophysiology (EP) procedures.
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