FDA grants 510(k) clearance for ureteroscope system LithoVue
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The FDA granted 510(k) clearance to Boston Scientific Corporation for its LithoVue Elite Single-Use Digital Flexible Ureteroscope System, according to a press release.
LithoVue is the first ureteroscope system that can monitor intrarenal pressure during ureteroscopy procedures. This tool can be used when diagnosing and treating problems in the urinary tract, such as kidney stones.
“Multiple studies have shown the importance of understanding intrarenal pressure during ureteroscopy procedures to mitigate potential complications, but until now, urologists have lacked an easy way to measure pressure in real-time,” Ben Chew, MD, MSc, an associate professor at University of British Columbia, said in the release. “This device represents an important and needed advancement in single-use ureteroscopes, which could help improve patient care and potentially lead to a clearer understanding of the impact of elevated intrarenal pressure on patient outcomes.”
Compared with the original LithoVue system, the Elite system includes upgraded image quality, control features and streamlined integration. According to the release, limited market release of the device in the U.S. will occur in the upcoming weeks.
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