Spinal Frontiers · Medtech & Innovation · AI & Emerging Tech
New planning, imaging, navigation, robotics and AI tools for spine surgery: what each does, whether it is cleared in the US and Europe, and what evidence stands behind it.
DePuy Synthes / SMAIO
Under a US sales agency agreement, DePuy Synthes will offer SMAIO's KEOPS-4ME platform, combining spinal alignment analysis, 3D planning and patient-specific K-ROD rods.
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Brainlab
The FDA cleared version 3.0 of Brainlab's spine planning software together with its Spine & Trauma Navigation and spinal alignment system (K262257). No company announcement was found, so feature details are not confirmed.
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MRI2CT
MRI2CT announced 510(k) clearance (K260525, decided 4 September) for NextMR, a cloud AI tool that builds 3D bone models of the lumbar spine and sacrum from routine 1.5T or 3T MRI in under a minute. Validation used 145 paired MRI-CT scans; the company says it is not a general replacement for CT.
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Globus Medical / Synaptive Medical
Globus announced it had bought Synaptive, a maker of cranial visualisation, navigation, planning and MRI technology, through a court-appointed receivership; the deal actually closed on 4 August 2026 and terms were not disclosed. Globus says it intends to link Synaptive's technology with its Excelsius enabling-technology ecosystem.
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Shanghai Changzheng Hospital
In a single-centre, assessor-blinded trial of 128 patients randomised 1:3, robot-assisted minimally invasive TLIF gave more accurate screws, less blood loss and a shorter stay but took longer, and its small early disability advantage had gone by three months. Fusion rates were similar; the trial was registered retrospectively and the authors call for larger multicentre studies.
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Medtronic
Time's 2026 best-inventions list included Medtronic's Stealth AXiS, citing its AI-assisted preoperative planning and real-time tracking of spinal motion during surgery.
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SpineCraft
SpineCraft received a US patent for a hybrid registration and tracking technology that avoids intraoperative radiation during image-guided open and minimally invasive spine surgery, the first of several planned patents in this area.
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Medtronic
Medtronic reported the first European cases with its integrated planning, navigation and robotics platform, with more than 23 procedures at seven sites in Germany, the UK, Italy and Spain by September. The system gained FDA 510(k) clearance for spine in February 2026.
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Siemens Healthineers
Siemens Healthineers introduced Vuze2 guidance software, which fuses preoperative or cone-beam CT with live X-ray to guide K-wire placement for pedicle screws without cameras, markers or patient reference frames. The report does not give its regulatory status.
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Enovis / eCential Robotics
Enovis made a binding offer to acquire Grenoble-based eCential Robotics, whose Op.n navigation-and-robotics platform is 510(k)-cleared for spine; closing is expected in Q4 2026 after French works-council consultation and regulatory approvals. Enovis put the upfront enterprise value at EUR 155 million, plus up to EUR 35 million in milestones.
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Spineart / eCential Robotics
A 510(k) clearance extends Spineart's Perla TL application on eCential Robotics' Op.n platform from navigation-only to robot-assisted workflows for open and minimally invasive pedicle screw placement. FDA decision 29 July (K261205); announced 28 August.
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SpineGuard
SpineGuard received a US patent for a robotically assisted ultrasound system that locates the pedicle entry point and drilling trajectory from the bony surface without X-rays. It is meant to complement the company's conductivity-based DSG guidance.
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Pulmera
Surgeons at Atrium Health Mercy Hospital in Charlotte used the newly 510(k)-cleared CBeam platform, which turns a standard 2D C-arm into an intraoperative 3D imaging source, to navigate three multilevel lumbar and cervical fusions. The cases mark the start of its US commercial launch.
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VB Spine / Augmedics
VB Spine took exclusive spine rights to Augmedics' technology that matches a preoperative CT to images from a standard 2D C-arm, adding a new registration route to the xvision augmented-reality headset system it bought earlier in 2026. Financial terms were not disclosed.
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Globus Medical
At NASS 2026 in San Antonio, Globus previewed SCRIPT, an FDA-cleared platform letting surgeons design patient-specific implants and plans that can be imported into ExcelsiusGPS or ExcelsiusHub. It also showed a prone XLIF positioning and retractor set.
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Carlsmed
A further 510(k) (K262149) was granted for the corra cervical plating system, ahead of Carlsmed's planned fourth-quarter cervical launch alongside its aprevo cervical interbody devices.
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Carlsmed / DeGen Medical
Carlsmed filed a patent infringement suit in South Carolina alleging DeGen Medical's products infringe eight of its patents on implants, methods and systems; DeGen says it will defend the claims.
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Carlsmed
Carlsmed said it intends to launch its corra cervical platform in the fourth quarter, extending its aprevo patient-specific business beyond the lumbar spine; it also expects new US MS-DRG codes from 1 October to add roughly $30,000 reimbursement per aprevo case. The report does not state corra's regulatory status.
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Houston Methodist / University of Cambridge
Researchers reported a flexible device placed around the spinal cord that, in preclinical work, detected movement-intention, sensory and visceral signals as a route to rerouting information past an injury. Human trials are not yet planned; work moves next to chronic-injury models.
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Neuralytix
The iD3 mechanomyography system, which gives the surgeon real-time objective readings of nerve changes during decompression without a neurophysiologist, became fully commercially available through US distributors. The report does not state its FDA status.
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SMAIO (US sales via DePuy Synthes)
Alignment analysis, 3D planning and patient-specific rods for deformity and degenerative surgery.
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Brainlab
Planning and navigation software suite with robotic alignment arm for spinal trajectories.
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EOS Imaging (ATEC)
3D alignment planning from biplanar EOS images, including AI-based landmark measurement (VEA Align).
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Medtronic (Medicrea)
Planning software for sagittal alignment that feeds patient-specific rod and implant manufacture.
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Aidoc
Flags suspected cervical spine fractures on CT for radiologist worklist prioritisation.
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Smart Soft Healthcare
AI that segments spine MRI, measures findings and drafts an editable radiology report.
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Nanox AI
Opportunistic analysis of chest/abdominal CT for vertebral compression fractures and bone density.
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MRI2CT
Cloud AI that generates CT-like 3D bone models of the lumbar spine and sacrum from routine MRI.
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Remedy Logic
AI reader that grades stenosis and other findings on lumbar MRI.
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Medical Metrics
AI analysis of spine radiographs measuring segmental and global spinal parameters.
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Surgalign (Holo Surgical); assets later sold
AI-based automatic segmentation and navigation system for spine.
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Pulmera
Upgrades a standard 2D C-arm to produce intraoperative 3D images for navigation.
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SpineGuard
Real-time electrical conductivity sensing at the drill tip to warn of pedicle breach.
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Globus Medical
Robotic navigation platform with a rigid arm for screw trajectory guidance; plans can now come from Globus's SCRIPT patient-specific software.
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Medtronic (Mazor Robotics)
Robotic guidance system for spinal screw trajectories integrated with StealthStation navigation.
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eCential Robotics (Enovis offer pending)
Combined 2D/3D imaging, navigation and active robotic guidance; Spineart's Perla TL app cleared for robotic use on it in August 2026.
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Proprio
Light-field camera system creating real-time 3D anatomy for radiation-light navigation, with AI features added in 2026.
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NuVasive (now Globus Medical)
Integrated platform for navigation, neuromonitoring, imaging enhancement, alignment and rod bending.
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Stryker
Optical navigation platform, cleared together with the Mako Spine robotic application.
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Zimmer Biomet (Medtech S.A.)
Robotic arm with navigation for spinal screw placement.
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Medtronic
Single platform combining AI-assisted planning, navigation and robotic guidance, with real-time tracking of spinal segment motion.
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Siemens Healthineers
Trackerless guidance fusing CT/cone-beam CT with live X-ray for pedicle K-wire placement.
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Neo Medical
AI/AR intraoperative data platform used with Neo Medical's fusion system.
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Novarad
Augmented-reality headset navigation overlaying imaging onto the patient for spine procedures.
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Augmedics (spine rights held by VB Spine)
Headset-based augmented-reality navigation projecting the 3D spine onto the surgeon's view; CT-to-fluoro registration added.
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Mighty Oak Medical
3D planning software and 3D-printed patient-specific pedicle screw guides.
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Carlsmed
AI-assisted planning and 3D-printed patient-specific interbody cages for lumbar and cervical fusion.
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Carlsmed
Personalised cervical plate, part of Carlsmed's cervical launch planned for Q4 2026.
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Medacta
3D-printed patient-matched drill guides for pedicle, cervical and S2-alar-iliac screws with web-based planning.
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Globus Medical
Surgeon-controlled design of patient-specific spinal implants and rods, with plans importable to ExcelsiusGPS/ExcelsiusHub.
Product page →Source checked
Regulatory status is taken from the FDA databases and company statements; 'none found' means we could not confirm a clearance, not that none exists. Any recall or safety notice on these tools appears in Regulatory Watch and on the home page.
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