Vessel-sealing instruments are important for many soft-tissue procedures because they allow surgeons to seal and divide blood vessels and tissue. Medtronic sold Hugo into the United States without one, because the platform’s first American clearance, granted in December 2025, covered urologic procedures only.
That gap closed on 16 September 2026, when the Food and Drug Administration cleared the LigaSure RAS Maryland instrument for use with Hugo; Medtronic announced the same day. The clearance lands three months after the company filed to widen Hugo’s US indications into general and gynecologic surgery.
The cleared instrument seals vessels up to 7 mm in about 2 seconds
LigaSure RAS Maryland seals and cuts vessels, thick tissue and lymphatics up to 7 mm in diameter, working in roughly 2 seconds while limiting thermal spread to surrounding tissue, the Medtronic newsroom confirmed. It runs only with the Valleylab FT10 energy platform on Hugo, and it is the first robotic-driven LigaSure device.
The underlying vessel-sealing technology has been used in more than 45 million procedures across over 65 countries in the past two decades, the company disclosed. Bringing that performance to Hugo in the US means surgeons keep the device they already know, the announcement stated.
“Surgeons carry the confidence and control they already rely on into their robotic-assisted cases” — Dr. Matthew Kroh, chief medical officer, Surgical business, Medtronic, in the company announcement of 16 September 2026
Kroh’s argument is commercial as much as clinical. Surgeons trained on LigaSure in open and laparoscopic work now meet the same energy device inside a robotic workflow.
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Hugo’s US clearance still covers urologic procedures only
The instrument clearance does not change what Hugo itself is licensed to do in the United States. Medtronic submitted 510(k) filings for a general surgery indication including hernia repair, and for a gynecologic surgery indication, on 3 June 2026.
The same announcement disclosed the LigaSure RAS filing and completed enrollment in the Embrace Gynecology investigational device exemption study, which included 70 patients across five US hospitals.
Outside the US, Hugo has been used in more than 35 countries across over 50 procedure types spanning urology, general and gynecologic indications, Medtronic reported. Europe received the same instrument in 2025 on CE mark, more than a year before the US decision.
Martha’s 50,000-procedure target needs the wider label
Medtronic’s Surgical business grew 9% globally in the first quarter of fiscal 2027. Martha described Surgical as the company’s largest operating unit, with more than $6 billion in annual revenue.
On the 1 September 2026 earnings call, chairman and chief executive Geoff Martha attached a number to Hugo’s year.
“We expect Hugo to surpass 50,000 completed procedures” — Geoff Martha, chairman and chief executive officer, Medtronic, in the fiscal 2027 first-quarter earnings call commentary
Martha set that mark for the end of a fiscal year that closes in late April 2027, and said procedure growth should hold at more than twice the market rate. The clearance is another step in Medtronic’s broader expansion of Hugo’s U.S. capabilities as it works toward its target of more than 50,000 procedures by fiscal year-end.
- Seal capability: Vessels, thick tissue and lymphatics up to 7 mm, in about 2 seconds (Medtronic, 16 September 2026)
- LigaSure base: More than 45 million procedures across over 65 countries in two decades (Medtronic, 16 September 2026)
- Hugo US indication: Urologic procedures only, cleared December 2025, with general and gynecologic filings submitted 3 June 2026 (Medtronic)
- Procedure target: More than 50,000 completed Hugo procedures by fiscal year-end in late April 2027 (Medtronic Q1 FY27 earnings commentary, 1 September 2026)
- Fiscal 2027 guidance: Organic revenue growth of 7.25% to 7.75% and adjusted EPS of $5.94 to $6.00 (Medtronic, 1 September 2026)
- MDT share price: Closed at $92.77 on the NYSE on 17 September 2026, up 0.18%, within a 52-week range of $73.31 to $106.33, according to StockAnalysis market data.
Medtronic raised its fiscal 2027 organic revenue growth guidance to a range of 7.25% to 7.75% on 1 September 2026, and lifted adjusted earnings guidance to $5.94 to $6.00 a share. The company has scheduled its investor day for 10 and 11 December 2026, where it said it would detail pipeline and capital allocation.
Intuitive’s installed base reached 11,710 da Vinci systems as of 30 June 2026, up 12% year-over-year, and worldwide da Vinci procedures rose 15% in the second quarter of 2026. Both gates opened on the same specialty within 72 hours. Gynecology is also the specialty Medtronic still cannot sell Hugo into in the US.
What the Hugo clearance means for Medtronic shareholders
The instrument gate is open, and the indication gate is not. Hugo remains cleared for urologic procedures only in the US, and the two 510(k) filings from June are still pending.
Two watchpoints carry dates. The FDA decisions on those filings determine whether general and gynecologic volume can contribute before the 50,000-procedure count closes in late April 2027, and the investor day on 10 and 11 December 2026 is when Medtronic said it would set out its pipeline and capital allocation.
