StoryRegulatory
Hugo RAS receives FDA 510(k) clearance for urologic surgery
Medtronic announced FDA 510(k) clearance for Hugo RAS for urologic procedures. Main competitor to da Vinci; US urology represents ~230,000 eligible procedures annually. First US cases began immediately.
- FDA clearance for prostatectomy, nephrectomy and cystectomy.
- Competes with da Vinci's established market position.
- US urology market: ~230,000 eligible procedures per year.
- Already in commercial use at 35+ countries globally.