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FDA Okays Boston Scientific's LithoVue Elite Single-Use Digital Flexible Ureteroscope System

Boston Scientific Corp. (BSX) said Friday that it has received a 510(k) clearance from the U.S. Food and Drug Administration for the LithoVue Elite Single-Use Digital Flexible Ureteroscope System, the first ureteroscope system with the ability to monitor intrarenal pressure in real-time during ureteroscopy procedures. Limited market release of the device in the U.S. will begin in the coming weeks.

Ureteroscopy is a common procedure performed by urologists to diagnose and treat a variety of problems in the urinary tract, most commonly kidney stones. Ureteroscopy is a common procedure performed by urologists to diagnose and treat a variety of problems in the urinary tract, most commonly kidney stones.

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