How Robotic Surgery Is Advancing in 2026

Originally published on The Daily Flare.

Robotic surgery is moving from a handful of big hospitals to a crowded field of competing systems, with annual procedure volumes passing three million and remote telesurgery crossing continents.

The story of robotic surgery in 2026 is one of acceleration. Intuitive Surgical's da Vinci systems, the long-standing leader, now assist in more than three million procedures a year. At the same time, three serious challengers — Medtronic's Hugo, Johnson & Johnson's Ottava, and CMR Surgical's Versius — have all won US market authorization, something no soft-tissue competitor managed for decades. Real-time AI is moving into the operating room, and surgeons have performed procedures across distances of 6,500 kilometers and more.

This tracker records the milestones from 2023 to 2026 and what comes next. Figures below come from company filings, investor disclosures, FDA records, or company press releases unless stated otherwise.

Robotic Surgery Milestones From 2023 to 2026

Intuitive remains the center of gravity. Its annual da Vinci procedure volume grew from about 2.286 million in 2023 to about 2.683 million in 2024 and about 3.153 million in 2025, according to its Form 8-K procedure data — growth of roughly 17 percent and then 18 percent year on year. More than 20 million patients have now been treated with Intuitive systems since 1997, and more than 3.1 million were treated in 2025 alone.

The installed base keeps expanding. Intuitive ended 2024 with roughly 9,902 da Vinci systems, reached about 11,106 by the end of 2025, and was near 11,710 by mid-2026, with the global base of da Vinci and Ion systems combined close to 13,000. In the second quarter of 2026, total procedures rose 16 percent, Ion lung-biopsy procedures jumped 36 percent to about 48,000, and 468 da Vinci systems were placed — 246 of them the new da Vinci 5.

The big regulatory moments, in order:

#	Date	System	Milestone
1	Mar 2024	da Vinci 5	FDA 510(k) clearance for Intuitive's fifth-generation system, with 150+ enhancements and force feedback
2	Oct 2024	Versius	FDA De Novo authorization for CMR Surgical's first-generation system
3	Dec 2025	Hugo	FDA 510(k) clearance for urologic procedures — first US-authorized soft-tissue da Vinci rival in decades
4	Dec 2025	Versius Plus	FDA 510(k) clearance (cholecystectomy) for the second-generation system
5	Jan 2026	da Vinci 5	FDA clearance for certain cardiac procedures (mitral valve repair, internal mammary artery mobilization)
6	Jul 2026	OTTAVA	FDA De Novo authorization — world's first table-integrated soft-tissue robotic system
7	Sep 2026	Hugo	FDA clearance of the LigaSure RAS Maryland vessel sealer for the platform

The da Vinci 5 clearance in March 2024 mattered because it introduced force feedback — surgeons can now feel tissue resistance through the console, a step toward restoring the sense of touch that robotic surgery had long lacked. A CE mark in Europe followed in mid-2025, and the January 2026 cardiac clearance added mitral valve repair and internal mammary artery mobilization, expanding Intuitive's addressable market by an estimated 160,000 procedures a year (an Intuitive estimate).

The single-port da Vinci SP has also been widening its territory indication by indication: simple prostatectomy in April 2023, the first single-port stapler in April 2025, transanal local excision in May 2025, and inguinal hernia repair, cholecystectomy, and appendectomy in December 2025, according to trade-press coverage. A CE mark for transvaginal gynecologic procedures followed on September 14, 2026. In the second quarter of 2026, 38 SP systems were placed, bringing the installed base to 445, with SP procedures up 61 percent year on year.

On the regulatory horizon, the FDA plans binding guidance on robotically assisted surgical systems for fiscal 2027, with the draft comment period closing November 24, 2026 — the first serious framework for how these machines will be regulated going forward. Verification against the FDA's 510(k) database remains the definitive way to check any individual clearance.

The Race to Compete With the da Vinci

For years, challengers stalled at the FDA's door. That wall is now coming down. Medtronic won 510(k) clearance for Hugo in urologic procedures — prostatectomy, nephrectomy, cystectomy — in December 2025, and the first US commercial case, a prostatectomy at Cleveland Clinic, followed on February 17, 2026. Hugo carries roughly five years of commercial experience abroad, with tens of thousands of procedures performed across more than 35 countries and hundreds of independently published papers supporting it. Medtronic expects Hugo to pass the 50,000-procedure mark by the end of its fiscal year (through April 2027), though that is forward guidance, not a confirmed result. In June 2026, Medtronic filed 510(k) submissions to expand US indications into general surgery, including hernia repair, and gynecology.

Johnson & Johnson's OTTAVA took a different route: instead of bolting robotic arms onto a cart, the system is integrated into the operating table itself. It received FDA De Novo marketing authorization on July 21/22, 2026, covering ten upper-abdominal general surgery procedures including Roux-en-Y gastric bypass, gastrectomy, cholecystectomy, splenectomy, and gastric sleeve. Its FORTE clinical study enrolled 30 patients across six US hospitals for Roux-en-Y gastric bypass and met all primary safety and performance endpoints at 30 days, with no conversions to non-robotic surgery. A selective US commercial launch is underway, with authorizations in Japan and Western Europe being pursued, an inguinal hernia pivotal trial ongoing, and a second FDA submission targeted for early 2027.

CMR Surgical's Versius positions itself as the second-largest soft-tissue robotics platform globally, with more than 45,000 patients treated across 30-plus countries as of March 2026 (a company figure reported at the SAGES 2026 meeting, not independently audited). Its first-generation system won FDA De Novo authorization in October 2024, and the second-generation Versius Plus cleared its 510(k) in December 2025 for cholecystectomy, with US commercialization in 2026. A 510(k) submission to expand US indications into gynecology was filed in April 2026.

Orthopedics tells a parallel story. Stryker's Mako, the robotic platform for joint replacement, passed a cumulative 2 million procedures in the second quarter of 2025, including more than a million robotic total-knee procedures alone, with systems in over 45 countries. The fourth-generation Mako 4 launched in 2025, alongside a new revision-hip application. Zimmer Biomet's ROSA platform is approaching 2,000 installations worldwide, and Zimmer completed a $177 million acquisition of Monogram Technologies in October 2025. Monogram's CT-based, semi-autonomous AI-navigated knee-replacement system won FDA 510(k) clearance in March 2025, with commercialization expected in early 2027 — and a clinical study for the fully autonomous version began in July 2025.

AI in the operating room took its clearest step yet on July 21, 2026, when Medtronic unveiled Touch Surgery Aide, a real-time AI compute platform built on NVIDIA Holoscan, CUDA, and TensorRT. Its first application, Instrument Exit Point, is FDA-cleared for Hugo. The direction here is layered real-time assistance — the system watching and advising during surgery — rather than full autonomy.

Telesurgery — a surgeon operating a robot from hundreds or thousands of kilometers away — moved from demonstration to milestone. In July 2026, MicroPort MedBot reported 10 consecutive cross-continental telesurgeries in about 11 hours, with a surgeon in Strasbourg, France operating on patients in Indore, India, roughly 6,500 km away, using its Toumai robot. SS Innovations reported a surgeon in Guyana operating on a patient in India — about 20,000 km of fiber distance — for a robotic cardiac intervention, and says it has performed 195 robotic telesurgeries as of September 28, 2026, with 244 systems installed in 12 countries and cumulative procedures of 14,503. On September 19, 2026, Nigeria saw its first reported tele-robotic surgery: a kidney-cancer procedure over roughly 500 km between the console in Ogun State and the patient in Abuja, using Starlink and MTN connectivity. These are company claims without independent verification, but they signal where investment and engineering effort are heading.

#	Figure	Value
1	da Vinci procedures 2025	~3.153 million (+18% YoY)
2	da Vinci installed base mid-2026	~11,710 systems
3	Cumulative Intuitive patients	>20 million since 1997
4	Mako cumulative procedures	2 million
5	ROSA installations	Approaching 2,000
6	Versius patients treated	>45,000 (company figure)
7	Longest reported telesurgery	~20,000 km (company claim)
8	Market size 2026	$13.7B–$16.1B (analyst estimates)

Analyst estimates for the surgical-robotics market diverge widely: The Business Research Company puts it at $13.69 billion in 2026 growing to $30.09 billion by 2030, while Towards Healthcare estimates $16.07 billion in 2026 growing to $63.73 billion by 2035. North America leads, Asia Pacific is the fastest-growing region, and instruments and accessories remain the largest revenue segment.

What's Coming Next

The next wave of decisions is already filed. Medtronic's June 2026 510(k) submissions for Hugo in general surgery and gynecology are pending, as is CMR's April 2026 submission for Versius Plus in gynecology. Clearance timelines are unverified, but approvals would open US markets for both platforms far beyond their current indications.

J&J's path runs through its inguinal hernia pivotal trial and a second FDA submission targeted for early 2027, alongside authorizations in Japan and Western Europe. Intuitive, meanwhile, is refreshing its installed base: the da Vinci 5 made up about 53 percent of second-quarter 2026 placements, and 42 refurbished XiR systems were placed in 2025, aimed at international markets and US ambulatory surgery centers. Intuitive's full-year 2026 guidance calls for 13.5 to 15.5 percent worldwide procedure growth — implying roughly 3.61 million da Vinci procedures, an estimate derived from the guidance range.

Autonomy is the longer horizon. Monogram's fully autonomous knee-replacement system entered clinical study in July 2025, with commercialization of the semi-autonomous version expected in early 2027; Zimmer aims to be the first orthopedic company with a fully autonomous robotic solution. On the soft-tissue side, Medtronic's Touch Surgery Aide suggests AI will arrive as real-time assistance layered into surgery rather than replacing the surgeon.

Telesurgery's commercialization will test regulators. SS Innovations is pursuing FDA clearance and EU CE marking for its SSi Mantra system, while the FDA's planned fiscal-2027 guidance will shape the US stance on remote procedures. Japan may also expand reimbursement for additional robotic procedures.