Caduceus S — AR Navigation

Navigation you never look away from

Caduceus S is an augmented reality navigation system for spinal surgery. It projects the navigation image into the surgeon's own line of sight, so the plan, the instrument and the anatomy stay in one view, without a monitor across the room.

FDA 510(k) cleared: K220554 (opens in a new tab), K242271 (opens in a new tab) · TFDA Class II license MOHW-MD-No. 008401

What it is

Augmented reality, brought into the surgical field

Caduceus S is an image-guided navigation system for percutaneous spine procedures. A transparent near-eye headset lets the surgeon look at the patient and at the navigation images at the same time.

What the system does

  • Headset display — the headset displays 2D stereotaxic screens and a 3D anatomy model
  • Instrument tracking — optical tracking shows the location of tracked surgical instruments relative to the patient's acquired scan
  • Posterior pedicle screw placement — the navigation image is available throughout percutaneous spine procedures
  • Planning — pedicle screw implant size planning and navigation on rigid bone structures
Caduceus S system: cart with tracking camera and display, headset, and connected unit

AR navigation in action

Why augmented reality for spinal surgery?

Augmented reality merges the imaging with the real surgical environment rather than putting it on a screen beside it. Six features of the system are described below.

A live case, seen the way the surgeon sees it

This footage shows a procedure in a real operating room.

Image in front of the surgeon

Conventional navigation shows the image on a screen on the far side of the room. With Caduceus S the image is displayed in front of the surgeon.

Registration from the C-arm images

Registration is done from the C-arm images themselves.

Imaging in the field of view

The headset projects the navigation images into the surgeon's field of view.

Tracked instruments

Shows the location of tracked surgical instruments relative to the patient's acquired scan.

Headset display

2D stereotaxic screens and a 3D anatomy model.

CT or C-arm images

Navigation from images acquired preoperatively by CT or intraoperatively by C-arm.

Features

In the operating room

The navigation image is displayed where the surgeon is looking.

Intuitive imaging, in the surgeon's own line of sight

The navigation image is displayed directly in the surgeon's field of view, so position can be checked without looking at an external monitor.

Surgeons working around a draped patient in an operating room, two of them
                  wearing the Caduceus S headset, with an instrument tray in the foreground.
A surgeon wearing the Caduceus S headset and a colleague hold a tracked
                    instrument together in an operating room.

The headset and a tracked instrument

A surgeon and an assistant work with a tracked instrument, the headset in use.

A surgeon wearing the Caduceus S headset holds a tracked instrument while colleagues look on in an operating room.

Colleagues looking on

A surgeon wearing the headset holds a tracked instrument while colleagues look on.

The team in the operating room

A surgical team works around a draped patient in an operating room, two members wearing Caduceus S headsets.

A surgical team works around a draped patient in an operating room, two members wearing Caduceus S headsets.

Caduceus S is cleared by the US FDA under 510(k) (K220554, K242271) and licensed as a Class II medical device by Taiwan's TFDA and the Thai FDA, and is manufactured under an ISO 13485:2016 quality management system. See every clearance and license in full

Percutaneous procedures

Navigation on CT or C-arm images

Caduceus S supports image-guided navigation of medical image data acquired preoperatively by CT or intraoperatively by C-arm, in percutaneous spine procedures.

Instrument tracking

The system shows the location of tracked surgical instruments relative to the patient's acquired scan.

A surgeon wearing the Caduceus S headset holds a tracked instrument while an
                  assistant in a surgical cap looks on, in an operating room.
Members of a surgical team work together with a tracked instrument, one wearing the Caduceus S headset.

A team with a tracked instrument

Members of a surgical team work together with a tracked instrument in an operating room.

A surgeon in profile wearing the Caduceus S headset in an operating room
                    with teal walls, colleagues working behind.

A surgeon wearing the headset

A surgeon in profile wearing the Caduceus S headset in an operating room.

Imaging modules

Navigation on the imaging in the room

Caduceus S supports image-guided navigation of medical image data acquired preoperatively by CT or intraoperatively by C-arm. Three modules match the imaging device in the room: a 2D C-arm, a 3D C-arm or an intraoperative CT.

Aspect 2D C-arm module 3D C-arm module Intraoperative CT module
Imaging source A standard 2D C-arm A 3D C-arm An O-arm intraoperative CT
Registration Performed from the C-arm images themselves Automatic, once the 3D scan is complete Automatic, once the CT scan is complete
Equipment Supports multiple C-arm brands Various registration tools; DICOM loaded into the navigation workstation O-arm, with no extra connections or configuration

All three columns are Caduceus S modules, not separate products. Which one is used depends on the imaging device in the operating room.

2D C-arm module

Registration is performed from the C-arm images themselves.

3D C-arm module

The reconstructed volume, the planned trajectory and the instrument position sit on one screen.

Registration

Various registration tools are supported, and DICOM images load straight into the navigation workstation.

Intraoperative CT module

The intraoperative CT module pairs Caduceus S with an O-arm. The scan is taken in theater, on the patient as they are positioned, and the navigation runs on that scan. X-ray images can be brought into the navigation alongside the CT.

For multi-level cases involving four or more levels, the 3D C-arm module takes the 3D scan, registers it automatically and drives navigation from it.

A surgeon wearing the Caduceus S headset raises an instrument at the operating table, with operating lights and equipment behind.

Deployment settings

A hospital and an outpatient center need different things

Caduceus S is one system with more than one shape. A hospital with 3D imaging or an intraoperative CT can navigate from a volume; an outpatient surgery center with a single 2D C-arm can run the same AR-guided procedure without buying one.

Hospitals

For hospitals the system adds a 3D C-arm module and an intraoperative CT module — O-arm or a hybrid OR. It builds the 3D image during the case and projects it onto the surgical area through AR, and the surgeon can pick between three perspectives as the procedure demands.

Both modules attach to imaging equipment the hospital already owns, so the move to AR navigation is a change of workflow rather than a capital purchase. Which module runs is the hospital's choice, depending on the imaging available.

The individual imaging modules — 2D C-arm, 3D C-arm and intraoperative CT — are described in the Imaging Modules section.

A surgical team in an operating room with teal walls, a surgeon on the right
                  wearing the Caduceus S headset and a C-arm beside the operating table.

Outpatient and ambulatory surgery centers

The case for OSCs and ASCs is largely financial. Caduceus S navigates from a standard 2D C-arm, so a center can offer AR-guided spinal surgery without investing in 3D imaging. No intraoperative CT is needed, and no second imaging device to find room for.

It adapts to the room rather than the other way round — large theater or small procedure room — and the same system navigates from either imaging setup, so the choice stays with the surgeon and the patient in front of them.

Caduceus S navigation cart, view 1 of 6: front Caduceus S navigation cart, view 2 of 6: turned to the left Caduceus S navigation cart, view 3 of 6: turned to the right, with the tracking camera arm Caduceus S navigation cart, view 4 of 6: left side Caduceus S navigation cart, view 5 of 6: right side Caduceus S navigation cart, view 6 of 6: from a lower angle

In either setting the clinical work is the same: the system is FDA 510(k) cleared for posterior pedicle screw placement.

Caduceus S — laptop version

Portable AR navigation

The same navigation, running on a laptop. Deployable across operating rooms and portable between theaters.

One module, no cart

The laptop version supports one navigation module per software installation, chosen at purchase: the C-arm module, the 3D C-arm module, or the I-CT module as an option. Everything else — the AR projection and the positioning functions — is what the full system does.

  • Compact and mobile — no bulky equipment
  • Spine implant and MIS procedures — the same two families of case the cart-based system is used for
Caduceus S laptop version: a laptop showing the navigation images, a tracking camera on a stand, and the headset

Regulatory status

Clearances, licenses and availability

Caduceus S (marketed as Caduceus S AR) is FDA 510(k) cleared (K220554, K242271) and licensed as a Class II medical device by Taiwan's TFDA and the Thai FDA. It is not CE marked and is not available for sale or use in the European Union. Availability differs by country; please contact us about your country.

Augmented reality navigation

See it in your own operating room

Tell us what imaging you already have — a 2D C-arm, a 3D C-arm, an intraoperative CT — and the procedures you run most often, and we will show you the configuration that fits. Online, or on site with the system in front of you. If you are near our US office in Naples, Florida, we can bring the demo to you.