97 Surgical AI Devices Are FDA-Cleared: What They Actually Do
The FDA lists 1,614 AI-enabled medical devices with decisions through June 29, 2026.
Of those, 97 are used in or around the operating room, which is about 6 percent of the list.
Most of them are not robots.
Navigation and planning make up most of the list
Navigation and guidance tools account for 31 clearances, the largest group.
Surgical planning software follows with 27.
Together the two groups make up 58 of the 97 clearances, or about 60 percent.
Navigation systems help a surgeon see where an instrument sits inside the body, mostly in brain, spine, and orthopedic surgery.
Planning software helps a surgical team map an operation before it starts, from spine alignment to joint replacement.
Brainlab appears on 9 of the 97 entries, more than any other company.
Robots are the smallest slice
Robotic systems account for only 8 of the 97 clearances.
Those 8 come from five systems: Senhance from TransEnterix, HYDROS from Procept BioRobotics, TMINI from THINK Surgical, Maestro from Moon Surgical, and Mazor X.
Seven of the 8 were decided between August 20, 2024 and October 10, 2025.
The robotics group has no new entry in 2026 through June 29.
Intuitive Surgical appears on the list only for IRISeg, an imaging software tool, and not for a da Vinci robot.
Endoscopy and the operating room itself
GI endoscopy AI accounts for 23 clearances, mostly software that flags polyps during colonoscopy.
Cosmo's GI Genius and Iterative Health's SKOUT each appear 6 times.
Intraoperative AI, meaning tools that work during the operation itself, has just 8 clearances.
That group includes SurgiCount+ from Stryker Instruments and the Instrument Exit Point feature on Touch Surgery Aide from Covidien.
Clearances are arriving faster each year
The yearly count rose from 2 in 2016 to 15 in 2023, 17 in 2024, and 25 in 2025.
Fifty-five of the 97 clearances came in 2024, 2025, and the first half of 2026.
The year 2026 already holds 13 through June 29.
Ninety-three of the 97 went through the 510(k) route, which compares a new device with one that is legally marketed.
Two went through PMA, the Dune MarginProbe System and the Claire OCT System.
Two went through De Novo: GI Genius and NaviCam ProScan.
The count measures clearances rather than products, because SIS software from Surgical Information Sciences appears 7 times and GI Genius appears 6 times.
What the pattern means for surgeons
Surgical AI is arriving first as software around the operation rather than as a robot inside it.
Navigation, planning, and endoscopy tools together make up 81 of the 97 clearances.
A clearance shows that a device reached the market, and the Surgical AI Claims Report checks what each company says its AI does against the evidence behind it.
How this count was built
The FDA list does not label devices as surgical, so NextInSurgery sorted entries by FDA product code and device name into five groups.
Cardiac interventional tools, radiation therapy planning, and general imaging systems were excluded.
GI endoscopy AI is counted as its own group, and removing it would leave 74 clearances.
A clearance shows that a device reached the market, and the Surgical AI Claims Report checks what each company says its AI does against the evidence behind it.
