Novasys: Using Clinical Trials to Drive Adoption for Incontinence
Executive Summary
Novasys Medical is using radio frequency (RF) energy to treat stress urinary incontinence in women. The company chose to adopt a much more rigorous and expensive clinical trials strategy than was needed to gain FDA approval of its device. This approach flummoxed the FDA,, slowing approval of the company's IRenessaI system. Novasys is betting that the enhanced data collected from its clinical study will result in the company gaining faster reimbursement that it hopes will drive adoption.
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This article was adapted from "Building Interventional Gynecology," which appeared in START-UP, June 2010.
Women's Health: Building Interventional Gynecology
This article was adapted from "Building Interventional Gynecology," which appeared in START-UP, June 2010.
Building Interventional Gynecology
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