Medtronic Files 510(k) for Hugo RAS in Hernia and Gynaecologic Surgery
MDT•Medtronic filed multiple 510(k) applications seeking FDA clearance for Hugo RAS in hernia repair and gynaecologic surgery while securing ProGrip Advanced mesh clearance and completing enrollment of 70 patients in its Embrace Gynaecology IDE trial. The company flagged FY26 as a turning point and kept strong FY27 targets while highlighting CAS platforms.
1. Regulatory Filings for Hugo RAS Expansion
Medtronic submitted 510(k) applications to the FDA for Hugo RAS system indications in general surgery, including ventral hernia repair, and gynaecologic procedures. These filings aim to broaden the system’s use beyond its current urologic applications in the US, where Hugo RAS has been available since December 2025.
2. Device Clearances and Clinical Trial Progress
The company also applied for 510(k) clearance of the LigaSure RAS Maryland instrument, compatible with its Valleylab FT10 platform, and received clearance for its ProGrip Advanced mesh, used in over six million procedures. Concurrently, Medtronic completed enrollment of 70 patients across five US hospitals in its Embrace Gynaecology IDE study, evaluating Hugo’s safety and effectiveness in robotic-assisted gynaecologic surgery.
3. Financial Outlook and Growth Targets
During its Q4 earnings call, Medtronic described FY26 as a turning point driven by CAS and new platforms, and reiterated robust FY27 growth targets despite investor concerns over tariffs and TAVR headwinds. The company emphasized its strategy to integrate instruments, intelligence and human expertise into a unified surgical ecosystem to capture demand in high-volume fields.
