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In Brief: Urohealth

This article was originally published in The Gray Sheet

Executive Summary

Urohealth: Receives conditional IDE approval from FDA for clinical trials of RelaX, a valved intraurethral catheter for the management of female incontinence. The device is designed to be left within the urethra for 29 days. Urohealth claims that possible advantages of the Relax over similar devices such as UroMed's Reliance include decreased risk of infection, convenience and "ease of use." Unlike the Reliance, the Relax can be used during sexual intercourse, the company adds. Relax is priced "competitively" at approximately $110 a month or $1200-1500 a year. The conditional IDE approval allows the company "to begin filing for investigational review board (IRB) approvals at designated clinical sites around the country and to begin clinical trials as the IRBs approvals are granted." The company plans on conducting clinical trials with approximately 130 patients at up to 12 sites...

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