aprevo® Digital Segmentation
Overview
aprevo® Digital Segmentation by Carlsmed is an AI-enabled software application designed to segment bony structures of the spine from patient imaging data. It serves as the foundational digital component of the broader aprevo® personalized surgery platform, converting standard CT scans into precise, patient-specific 3D models of the spinal anatomy.
The software is designed for spine surgeons, neurosurgeons, and orthopedic surgeons operating in hospital and ambulatory surgical settings. It supports clinical workflows for both lumbar and cervical spinal fusion procedures.
In a typical clinical workflow, the software processes a patient’s CT scan to generate a detailed 3D anatomical model. Surgeons utilize this model to perform preoperative planning, customize spinopelvic alignment parameters, and design patient-specific, 3D-printed interbody fusion devices tailored to the individual’s unique anatomy.
Notable Capabilities:
- AI-Driven Image Segmentation: Automates the identification and reconstruction of complex spinal bony structures from CT imaging.
- Anatomical Modeling: Generates high-fidelity 3D spinal models to assist in preoperative visualization and surgical strategy formulation.
- Workflow Integration: Connects directly with the myaprevo® ecosystem to transition digital plans into custom-manufactured, 3D-printed titanium implants delivered sterile to the operating room.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-based algorithm for automated spine segmentation
- DICOM image input processing
- Generation of 3D models of spinal structures
- Tools for importing and visualizing medical images
- Functionality to check and correct segmentations
- Supports personalized surgical planning
- Part of an integrated platform for patient-specific implant design
Use Cases
- Digital image segmentation of lumbar and cervical spine anatomy
- Creation of precise 3D anatomical models for surgical planning
- Foundation for designing patient-specific spinal fusion implants
- Pre-operative visualization and assessment of spinal deformities
What Physicians Need to Know
aprevou00ae Digital Segmentation is designed for trained medical personnel to enhance personalized surgical planning by leveraging AI-enabled segmentation and prior outcomes data. This tool aids in achieving precise alignment and predictable surgical outcomes, potentially leading to reduced revision rates and improved patient satisfaction. Users can review and correct segmentations, and the myaprevou00ae app provides detailed 3D plan visualizations to support intraoperative execution. The platform is integral to pre-operative, intra-operative, and post-operative workflows, enabling a tailored approach to spine surgery.
The aprevou00ae Digital Segmentation tool accepts DICOM images as input and generates 3D models as output. These outputs can be integrated and reviewed within the broader surgical workflow using third-party software. The system is part of the comprehensive aprevou00ae platform, which combines AI-enabled software and clinical intelligence to deliver personalized surgical strategies and preoperative planning, supporting an end-to-end digital surgery platform.
Details
| Category | Radiology & Imaging AI, Surgical AI |
| Pricing | Contact for pricing |
| Deployment | Not specified |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
Yes AI-estimated The aprevo® Digital Segmentation software received FDA 510(k) clearance (K231955) on November 3, 2023, as a Class II medical device (21 CFR §892.2050, Medical Image Management and Processing System). It is intended for trained medical design personnel to perform digital image segmentation of the spine, primarily lumbar anatomy, from DICOM images to output 3D models. |
| Integrations | |
| EHR | Not specified |
| Specialties | Neurosurgery, Orthopedics, Radiology |
What the Web Says
Carlsmed's aprevou00ae Digital Segmentation is an AI-enabled software platform that creates personalized 3D surgical plans and patient-specific spinal implants for fusion surgeries. It aims to improve surgical outcomes, reduce reoperations, and enhance patient quality of life by achieving precise anatomical fit and optimal alignment. The technology has received FDA clearance and breakthrough device designation for cervical use, with commercial launches expanding to various lumbar and cervical fusion procedures.
Overall: PositiveStrengths
- Improved surgical outcomes and alignment compared to traditional methods.
- Reduced complication-related reoperations.
- Patient-specific implants designed for precise anatomical fit and optimal alignment.
- AI-enabled preoperative planning and digital production system.
- Seamless integration with surgical workflows and supports various spinal pathologies and approaches.
- Potential for reduced healthcare costs due to fewer revisions.
Limitations
- Early in clinical development with limited long-term evidence of efficacy and safety.
- Unclear information regarding cost and insurance coverage.
- Some comparisons to stock implant outcomes are based on previously published or separately reported clinical data rather than direct head-to-head studies.
Based on reviews from: Becker's Spine Review, Medical Device and Diagnostic industry, ODT Magazine, Quiver Quantitative, Carlsmed (carlsmed.com), FDA.report, Reddit, Personalized Spine, accessdata.fda.gov
Last updated: 2026-07-20
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