MRI2CT Clears FDA Hurdle for AI Spine Imaging

MRI2CT has won FDA 510(k) clearance for NextMR Spine, AI software that turns a patient's standard diagnostic MRI into a 3D bone visualization of the lumbar spine and sacrum — without an additional CT scan or added radiation. FDA's decision on the clearance, K260525, is dated 4 September 2026; the private, Jerusalem-based company announced it publicly a month later, on 7 October 2026.

A Jerusalem team's undisclosed start

From a 2025 validation paper to a first clearance

1. Prior to 2025

   Jerusalem R&D team formed

   MRI2CT, Inc. is incorporated in Claymont, Delaware, with its research and engineering team based in Jerusalem, Israel. The company has not published a founding date.

2. 18 April 2025

   Validation science published

   The Journal of Clinical Medicine publishes “Generating a Synthetic Lumbar CT from a Standard MRI Protocol,” co-authored by MRI2CT's CTO with spine surgeons at Rush and Johns Hopkins, reporting submillimeter accuracy across 500 vertebrae measurements against CT.

3. 17 February 2026

   510(k) submitted

   MRI2CT files its 510(k) application for NextMR Spine with FDA.

4. April 2026

   Roadmap disclosed

   At Israel's Kenes Biomed conference, the company describes initial revenue and an unnamed spine-industry collaboration, and lays out plans to expand beyond the lumbar spine.

5. 4 September 2026

   FDA clearance decision

   FDA's own device database records the clearance decision for K260525 — MRI2CT's first listed clearance.

6. 7 October 2026

   Clearance announced publicly

   MRI2CT publicly announces the FDA clearance, about a month after FDA's recorded decision date.

7. Ahead

   Full spine and new anatomies

   The company's own roadmap describes expanding beyond the lumbar spine and sacrum, lowering its age floor to 12, and adding other orthopedic anatomies, with no confirmed public timeline.

NextMR Spine's clearance, in four figures

<60 secto generate a 3D bone visualization from a standard MRI, per the company

145adults in the retrospective U.S./Israel dataset MRI2CT cites for its submillimeter accuracy claim

K260525the 510(k) number FDA cleared, decision dated 4 September 2026

1stclearance on record for MRI2CT, per FDA's own device database

Figures from FDA's 510(k) database (K260525) and MRI2CT's October 2026 announcement as reported by AuntMinnie and Diagnostic Imaging.

Why the clearance arrived a month late

FDA's own device database records a decision date of 4 September 2026 for K260525 — MRI2CT's 510(k) for NextMR Spine. The company did not announce the clearance publicly until 7 October 2026, about a month later, a gap the Business Wire release and its trade-press pickup do not explain. The clearance itself covers software that takes a patient's standard 1.5T or 3T diagnostic MRI and, in under 60 seconds by the company's account, produces a 3D bone visualization of the lumbar spine and sacrum — viewable in standard imaging planes or as a 3D reconstruction, without the patient returning for a CT scan. FDA's own labeling caveat, repeated across trade coverage, is specific: NextMR Spine images “are not intended to replace CT images in general.”

“Patients commonly begin their spine journey with an MRI, while detailed 3D visualization of bone may require another imaging step,” CEO Shmulik Shpiro said of the clearance. Dr. Frank Phillips, director of the Section of Minimally Invasive Spine Surgery at Midwest Orthopaedics at Rush — and a co-author on MRI2CT's own 2025 validation paper, a relationship worth disclosing rather than treating him as a disinterested outside voice — was quoted saying the tool could mean “avoiding additional imaging, radiation and appointments.”

“Patients commonly begin their spine journey with an MRI, while detailed 3D visualization of bone may require another imaging step.” Shmulik Shpiro, CEO, MRI2CT — 7 October 2026 announcement

Built for a scan patients already get

MRI2CT's own peer-reviewed science, published in the Journal of Clinical Medicine in April 2025, reported submillimeter accuracy across 500 vertebrae measurements when its algorithm's synthetic bone output was checked against real CT scans — a smaller, published study distinct from the 145-adult retrospective dataset the company cites for the FDA submission itself, which has not been separately peer-reviewed. The company's pitch, repeated across its FDA clearance coverage, is that NextMR works on the conventional MRI sequences hospitals already run, rather than a specialized pulse sequence that would need new scanner software.

Three things NextMR Spine is built around

01

No added scan or radiation

NextMR Spine works from the diagnostic MRI a patient has already had, rather than requiring a separate CT scan — the rationale its CEO and an outside spine surgeon both cite for the clearance.

02

Works on routine MRI scans

The software runs on conventional 1.5-tesla and 3-tesla MRI sequences, unlike research-stage Zero Echo Time bone-imaging techniques that need a specialized pulse sequence and vendor-specific reconstruction software.

03

Cloud-based, under a minute

Output generates in under 60 seconds through a web interface or DICOM-compatible systems, with no local software installation, by the company's account.

A narrow slice of a billion-dollar navigation market

NextMR Spine competes for a place in the broader spine-navigation and surgical-planning market, where CT-based systems remain the default. Grand View Research sized the U.S. orthopedic spine navigation systems market at $185.8 million in 2022, forecasting growth to $459.8 million by 2030 at a 12.4% compound annual rate — a market still small enough that an MRI-only entrant could carve out a meaningful niche without displacing CT-based incumbents.

Spine navigation's climb to $459.8 million

$185.8M → $459.8M

U.S. orthopedic spine navigation systems market, 2022 to 2030, as forecast by Grand View Research.

2022$185.8M

2030$459.8M

Sources: Grand View Research, U.S. Orthopedic Spine Navigation Systems Market Report

Regulatory News outlook

We expect MRI-only bone-visualization tools like NextMR Spine to start at a low-single-digit share of U.S. instrumented spine procedures rather than displace CT-based navigation outright — on the order of 16,000 to 32,000 procedures a year within two to three years.

How we got here: iData Research's estimate of roughly 1.62 million annual U.S. instrumented spine procedures, at an assumed 1% to 2% initial adoption rate for a newly cleared, single-indication tool, yields approximately 16,000 to 32,000 procedures a year.

NextMR Spine against how surgeons see bone today

Product	Input imaging	Added radiation?	Validation	U.S. regulatory status
NextMR Spine (MRI2CT)	Standard diagnostic MRI (1.5T/3T)	No added scan	145-adult retrospective dataset, submillimeter cortical accuracy (company-reported)	FDA cleared, Sep 2026 (K260525)
BoneMRI (MRIguidance)	Dedicated MRI protocol	No added scan	73-patient retrospective cohort (lumbar spine)	FDA cleared, Nov 2022 (lumbar spine follow-on to K221762)
Excelsius GPS (Globus Medical)	Pre-operative and intra-operative CT, fluoroscopy	Yes — CT- and fluoroscopy-based	Company and published navigation-accuracy literature	FDA cleared, August 2017

From each company's own labelling, FDA's device database and published announcements; not a clinical comparison.

What a debut clearance still has to prove

FDA's device database lists K260525 as MRI2CT's first and, to date, only clearance — this is a debut product finding its first customers, not an established platform adding an indication. The company's own April 2026 conference materials describe “initial revenues and a collaboration with a leading spine player,” neither named, and a roadmap toward full-spine coverage, a lower age limit of 12, other orthopedic anatomies, and integration with third-party surgical navigation and robotics platforms — none of it on a confirmed public timeline. No funding round, investor or dollar figure has been disclosed.

• Scope: covers only the lumbar spine and sacrum in adults; FDA's labeling caution says images “are not intended to replace CT images in general.”
• Validation: the 145-patient accuracy claim behind the clearance has not been published as a standalone peer-reviewed study, unlike the company's smaller 2025 paper.
• Funding: undisclosed. The company describes “strategic and physician investors” without naming any or stating an amount raised.
• What's next: full-spine and additional-anatomy expansion, and deeper ties to surgical navigation and robotics platforms, per the company's own April 2026 roadmap — with no confirmed dates.

Frequently asked questions

What did FDA clear for MRI2CT?

NextMR Spine, AI software (510(k) K260525) that generates a 3D bone visualization of the lumbar spine and sacrum from a standard diagnostic MRI, with no additional scan. FDA's decision is dated 4 September 2026; the company announced it publicly on 7 October 2026.

Does NextMR Spine replace a CT scan?

No. FDA's clearance and the company's own labeling state that NextMR Spine images are not intended to replace CT images in general. It is a visualization aid built from an MRI the patient has already had, not a diagnostic substitute for CT.

Is this MRI2CT's first FDA clearance?

Based on FDA's own device database, yes — K260525 is the only clearance on record for MRI2CT, Inc.

How was NextMR Spine validated?

MRI2CT cites a retrospective dataset of 145 adults with paired MRI and CT scans from sites in the United States and Israel, reporting submillimeter accuracy in outlining cortical bone. That is a company-reported figure relayed by trade press, distinct from the smaller, peer-reviewed 500-vertebrae study the company's scientists published in 2025.