Medtronic has submitted several regulatory filings to the US Food and Drug Administration (FDA) as it seeks to broaden the scope of its Hugo robotic-assisted surgery (RAS) system for use in general and gynaecologic surgery.
The company, which has offered the Hugo system for urologic procedures in the US since December 2025, announced the new milestone filings.
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The submissions include 510(k) applications for indications such as hernia repair and gynaecologic surgery.
Medtronic also filed for 510(k) clearance of the LigaSure RAS Maryland instrument, which is designed to be compatible with its Valleylab FT10 energy platform and the Hugo RAS system.
According to the company, LigaSure vessel-sealing technology has been used in more than 35 million procedures across over 65 countries.
Medtronic also reported receiving 510(k) clearance for its ProGrip Advanced mesh, which is intended for robotic-assisted ventral hernia repair.
The ProGrip mesh line has previously been used in more than six million procedures, and the new version aims to improve handling and deployment through minimally invasive approaches.
The company also confirmed the completion of patient enrolment in its Embrace Gynaecology investigational device exemption (IDE) clinical study.
The trial is evaluating the safety and effectiveness of the Hugo system during robotic-assisted gynaecologic procedures and has enrolled 70 patients at five hospitals in the US.
Medtronic stated that expanding the indicated use of its Hugo system is intended to address the growing demand for minimally invasive surgery options in high-volume fields such as general and gynaecologic surgery.
The system is already in clinical use for these indications in several markets outside the US.
Medtronic senior vice-president and surgical business president Matt Anderson said: “These milestones and innovative technologies will unlock our ability to enhance the value of our partnership in general and gynaecologic surgical procedures.
“This isn’t just a portfolio expansion; it’s part of our ongoing commitment to unite instruments, intelligence, and human hands into one unique surgical ecosystem. One that enables every patient, everywhere, access to the best possible surgery.”
Last month, Medtronic received the CE mark for its VitalFlow Transport Frame Air and Ground, which functions as an accessory to the VitalFlow extracorporeal membrane oxygenation system.
