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In Brief: Rochester Medical

This article was originally published in The Gray Sheet

Executive Summary

Rochester Medical: Gains 510(k) clearance March 13 to market a catheter that "has tremendous potential as a self-use female incontinence device and for use as a preferred replacement for Foley catheters in females." The catheter, which is "completely hand actuated," eliminates the need for syringes, "can be easily self-inserted and self-removed," and includes a retention mechanism that may be activated "by a simple squeeze of the fingers," according to the Stewartville, Minnesota-based company. The device is intended for use in hospitals, nursing facilities and the home. A launch date has not yet been set...
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