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Medical Devices / Submissions and Approvals

FDA Clears Safe Medical Design’s Urinary Catheter

Feb. 15, 2019
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The FDA has given the go-ahead for urology devicemaker Safe Medical Design’s Signal Catheter for marketing in the U.S.

The device, a flexible tube that goes through the urethra and into the bladder to remove urine, has a design that can reduce incidents of urethral trauma caused by premature balloon inflation during placement.

Urethral trauma can cause patients expensive and lasting damage, as well as pain. It can also can also cause scarring that can block or slow urine flow.

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