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FDA clears Medtronic’s LigaSure RAS Maryland device

The Hugo RAS system is authorised for urologic surgery in the US and adopted by health systems nationwide.

Salong Debbarma September 17 2026

Medtronic has received clearance from the US Food and Drug Administration (FDA) for its LigaSure RAS Maryland jaw device for use with the company’s Hugo robotic-assisted surgery (RAS) system.

This decision introduces Medtronic’s vessel-sealing technology to surgeons performing robotic-assisted procedures in the US, further expanding the range of instruments available for the Hugo system.

The Hugo RAS system is currently authorised for use in urologic surgical procedures in the US and has been adopted by an increasing number of health systems and hospitals across the country.

Medtronic stated it is working towards expanding the indications for the Hugo system to include a wider range of soft-tissue surgical procedures, covering both general and gynaecologic surgeries.

Outside the US, the Hugo RAS system has seen use in over 35 countries, across more than 50 types of surgical procedures in urology, general surgery, and gynaecology.

The LigaSure RAS Maryland instrument is designed solely for use with the Valleylab FT10 energy platform on the Hugo RAS system.

The device is capable of sealing and cutting vessels, thick tissue, and lymphatics up to 7mm in diameter, with vessel sealing reportedly taking approximately two seconds while reducing thermal spread to nearby tissue.

Medtronic Surgical business chief medical officer and practising surgeon Dr Matthew Kroh said: “Vessel sealing sits at the centre of how surgeons work through the most demanding moments of a procedure, and surgeons have trusted LigaSure to do it across open and laparoscopic surgery for decades.

“Bringing that same performance to the Hugo RAS system in the US means surgeons carry the confidence and control they already rely on into their robotic-assisted cases.”

The LigaSure RAS Maryland instrument was launched for use on the Hugo RAS system in Europe in 2025 following CE Mark certification.

Last month, Medtronic’s Sphere-9 catheter and Affera mapping and ablation system secured a CE mark in Europe for ventricular arrhythmia treatment.

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