NEW YORK, NY--(Marketwire -08/15/11)- 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 Radient Pharmaceuticals Corporation (Pinksheets: RXPC.PK - News) and Antares Pharmaceuticals, Inc. (AMEX: AIS - News). Access to the full company reports can be found at:
www.bedfordreport.com/RXPC
www.bedfordreport.com/AIS
Last month 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 FDA says it disagrees with the recommendations and wants to amend its current process, not overhaul it.
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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. In the most recent quarter the company announced an exclusive licensing agreement with Watson Pharmaceuticals, for the commercialization of Anturol gel, for treatment of patients with overactive bladder, which is currently under review by the Food and Drug Administration.
Currently Radient Pharmaceuticals offers its FDA-cleared In Vitro Diagnostic (IVD) Onko-SureTest Kit, which is used for the detection and/or monitoring of 14 different types of cancers. Onko-Sure has also received regulatory approval outside of the US as a general cancer tumor marker, as well as for lung cancer detection, treatment and recurrence monitoring.
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