Highly Scrutinized Medical Equipment and Supplies Sector Looks for FDA Clarity
October 24, 2011 08:16 ET
Highly Scrutinized Medical Equipment and Supplies Sector Looks for FDA Clarity
The Bedford Report Provides Stock Research on Antares Pharmaceuticals & Boston Scientific
NEW YORK, NY--(Marketwire - Oct 24, 2011) - 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 the outlook for companies in the Medical Equipment & Supplies Industry and provides investment research on Antares Pharmaceuticals, Inc. (
[ www.bedfordreport.com/AIS ]
[ www.bedfordreport.com/BSX ]
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 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.bedfordreport.com ] and get exclusive access to our numerous analyst reports and industry newsletters.
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.
Antares Pharma focuses on self-injection pharmaceutical products and technologies, and topical gel-based products and offers injection devices including Zomajet 2 Vision and Zomajet Vision X.
Boston Scientific Corporation is a worldwide developer, manufacturer and marketer of medical devices that are used in a range of interventional medical specialties. Last week the company reported an EPS of 9 cents during the third quarter of fiscal 2011 compared with 12 cents in the year-ago period.
The Bedford Report provides Investment Research focused on equities that offer growth opportunities, value, and strong potential return. We strive to provide the most up-to-date market activities. We constantly create research reports and newsletters for our members. The Bedford Report has not been compensated by any of the above-mentioned publicly traded companies. The Bedford Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at [ http://www.bedfordreport.com/disclaimer ]