StoryRegulatory

Hugo RAS receives FDA 510(k) clearance for urologic surgery

MedtronicHugo RAS

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.
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