MAKO Mako Surgical Corp. (MM)

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.

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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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