SMART PCFD

by Disior  · Based in Finland → — Making Medical Imaging Intelligent
Orthopedics Plastic Surgery Radiology
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Regulatory Status Disclosed

Overview

Disior, now a Paragon 28® Company, develops advanced 3D analytics software for clinicians, transforming traditional 2D medical images into objective numerical data and highly accurate 3D models. This innovative approach aims to revolutionize medical image analysis by providing precise data for diagnosis, treatment planning, and outcome assessment, thereby reducing human labor, lowering costs, and improving accuracy in patient care.

The software, including modules like Bonelogic®, offers anatomy-specific analysis for areas such as Foot & Ankle, Hand & Wrist, and CMF Orbital. It enables clinicians to make decisions based on accurate, consistent, and comparable data, which traditional 2D methods often cannot match.

Disior’s solutions are designed to streamline clinical workflows, offering rapid conversion of medical images into patient-specific analytics, virtual surgical planning with live bone alignment measures, and tools for engaging patients with compelling 3D visuals of their planned procedures.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • 3D analytics for medical images (CT, CBCT, MRI)
  • Transforms 2D images into numerical data and 3D models
  • Objective data for diagnosis, treatment planning, and outcome assessment
  • Automated, easy-to-use tools for accurate diagnosis
  • Accelerated patient throughput with reliable analysis (under 5 minutes)
  • Improved treatment outcomes through patient-specific surgery plans
  • DICOM compliant and PACS compatible
  • Virtual surgical planning with live bone alignment measures
  • Anatomy-specific modules (Foot & Ankle, Hand & Wrist, CMF Orbital)
  • Visualization and manipulation of 3D models in the clinic

Use Cases

  • Diagnosis of orthopedic conditions (e.g., osteoarthritis, fractures)
  • Pre-operative planning for foot, ankle, hand, wrist, and CMF orbital surgeries
  • Assessment of treatment outcomes
  • Patient-specific implant creation and virtual reconstruction
  • Reducing human error and time in medical image analysis
  • Engaging patients in their treatment with compelling visuals

What Physicians Need to Know

DICOM Support & Standards
SMART PCFD supports standard DICOM SOP classes for CT Image Storage and Enhanced CT Image Storage, with specific required DICOM attributes for case creation.
PACS Integration Method
The software integrates via a cloud service, sending DICOM data and user-defined parameters using HTTPS (TLS encryption, Port 443 TCP). DICOM data is de-identified in the cloud, processed, and results are returned as numeric data, with original DICOM data deleted.
Reading Room Workflow Impact
SMART PCFD aims to simplify clinical workflow by providing automated, accurate diagnosis and patient-specific surgical planning. It accelerates patient throughput by analyzing CT/CBCT scans in 3-4 minutes, saving significant manual work. It offers 3D visualization, measurements, and surgical planning capabilities.
AI Model Architecture (deep learning approach)
The software incorporates AI-powered algorithms and machine learning for 3D analytics, analyzing original 3D data rather than traditional 2D slices. The machine learning algorithms were developed using independent training, tuning, and validation datasets.
Processing Speed (per study)
SMART PCFD can analyze CT or CBCT scans in 3-4 minutes.
FDA Clearance Pathway (510k/De Novo)
SMART PCFD is expected to follow a 510(k) clearance pathway in 2025. A related device, SMART Bun-Yo-Matic CT, received 510(k) clearance (K240642) as a Class II medical image management and processing system, and SMART PCFD utilizes the same machine learning derived outputs.
Supported Modalities (CT/MRI/X-ray/US)
The intended medical image modality for SMART PCFD is weight-bearing CT (WBCT), and it also supports general CT and Cone Beam CT (CBCT) data.
Sensitivity & Specificity Data
While specific sensitivity and specificity data for SMART PCFD are not explicitly detailed, related Disior products utilizing similar AI technology have demonstrated high performance, such as 100% correctly identified bones of the foot and ankle and 98.8% correct metal identification (98% specificity, 100% sensitivity) in CT images. The software also boasts reliable analysis with an Intraclass Correlation Coefficient (ICC) greater than 0.96.
Physician Tip

Leverage SMART PCFD for rapid, automated 3D analysis of weight-bearing CT scans to gain objective data for diagnosing Progressive Collapsing Foot Deformity (PCFD) and for precise pre-operative surgical planning. The 3-4 minute processing speed can significantly accelerate patient throughput and support patient-specific treatment strategies, potentially leading to improved outcomes. The 3D visualization and measurement tools can also enhance patient education and understanding of planned procedures.

SMART PCFD operates as a cloud-based service, requiring an HTTPS connection for DICOM data transfer. Hospitals should ensure their IT infrastructure allows secure outbound connections (Port 443 TCP) to the Disior cloud service. The system de-identifies DICOM data in the cloud, ensuring patient privacy while leveraging advanced analytics.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Unknown
DeploymentCloud-based
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status 1 AI-estimated

The SMART PCFD software (K250023) is a Class II medical device cleared by the FDA. It provides visualization reports of 3D mathematical models and measurements of anatomical structures of the foot and ankle, 3D models of orthopedic fixation devices, measurement templates, and a surgical planning application for common flatfoot procedures, including Medial Displacement Calcaneal Osteotomy (MDCO), Lateral Column Lengthening (LCL), and Cotton Osteotomy (CO).
Integrations
EHR Not specified
Specialties Orthopedics, Plastic Surgery, Radiology

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Press & Coverage

FDA
510(k) Premarket Notification - SMART PCFD
This regulatory announcement details the FDA's clearance of SMART PCFD software, an AI-powered device for reviewing and digitally processing CT images for diagnosis and surgical planning of Progressive Collapsing Foot Deformity (PCFD). The software creates 3D models and provides measurements to support orthopedic healthcare professionals.
2025-09
Nyquist AI Blog
Data Update: October 2025 - New Device Approvals/Clearances
This blog post highlights recent FDA device approvals, including SMART PCFD by Disior Ltd., cleared on September 29, 2025, for radiology applications. It provides an overview of new device approvals and regulatory updates.
2025-10
X-ray Interpreter
SMART PCFD | FDA Radiology AI Device
SMART PCFD is described as an AI-powered software assisting orthopedic healthcare professionals in diagnosing and planning surgery for Progressive Collapsing Foot Deformity (PCFD) using weight-bearing CT images. It offers 3D models, measurements, and surgical planning tools.
2025-09
Physician AI Tools
Disior - Physician Ai Tools
This entry lists Disior's SMART PCFD as a radiology and imaging AI tool that provides 3D AI analytics software for clinicians, converting medical images.
2026-04
Paragon 28
Instructions for use - SMART PCFD
This document provides instructions for use of the SMART PCFD software, indicating its original release and how to access the planning features.
2026-03
X-ray Interpreter
Search FDA-cleared listings - Radiology AI Tools Directory
SMART PCFD by Disior Ltd. is listed in an FDA-cleared radiology AI tools directory, with a decision date of September 29, 2025, for radiotherapy planning.
2025-09

Videos

Product demos, reviews, and walkthroughs for SMART PCFD.

View all on YouTube

Frequently Asked Questions

The SMART28u2120 ecosystem, including modules like SMART Bun-Yo-Maticu2120, leverages AI, data analytics, and 3D modeling to create patient-specific surgical plans for foot and ankle conditions such as Progressive Collapsing Foot Deformity (PCFD). It transforms imaging data (X-rays or weight-bearing CT scans) into 3D models, allowing surgeons to visualize anatomy, detect abnormalities, and plan precise corrections in under ten minutes. This AI-driven planning can also be paired with instruments like the Bun-Yo-Matic Lapidus Clamp for reproducible intraoperative execution.
The SMART Bun-Yo-Matic CT software, a component of the SMART28u2120 ecosystem, has received FDA clearance for diagnosis and surgical planning for hallux valgus procedures using CT images. While specific FDA clearances for all PCFD-related modules within SMART28u2120 would need to be verified, AI tools in healthcare generally require rigorous clinical validation and regulatory review, often qualifying as Software as a Medical Device (SaMD). To ensure patient data privacy, AI systems in healthcare must comply with HIPAA, which necessitates robust data protection measures like encryption and controlled access, especially as large datasets are used for AI training.
Like many AI systems in orthopedics, SMART PCFD's algorithms may face limitations such as potential biases if the training data lacks diversity, leading to skewed results. There are also concerns about 'black box decision-making,' where the AI's reasoning for a specific output may not be transparent to human users, making error checking difficult. AI should augment, not replace, human expertise, as overconfidence and reliance on outdated information can prevent AI from outperforming surgeons in complex tasks.
Current alternatives to AI-driven surgical planning for foot and ankle deformities primarily involve traditional 2D imaging (X-rays) and manual preoperative planning. Surgeons typically rely on their experience and these 2D images, which can limit the view of complex anatomical structures. Other approaches include conventional orthotics and braces for conservative treatment, and various established surgical techniques without AI assistance.
The specific pricing for SMART PCFD is not publicly detailed, but startup costs for AI-powered surgical planning and navigation systems can range from $5,000 to $20,000, with development of complex AI platforms potentially exceeding $250,000. While direct cost-effectiveness data for SMART PCFD is not provided, AI in surgical planning aims to improve patient outcomes by enhancing precision, reducing unnecessary procedures, and potentially lowering healthcare costs by minimizing complications and radiation exposure.
The SMART28u2120 Case Management Portal allows surgeons to submit patient imaging, including weight-bearing X-rays or CT scans, and serves as a direct communication line with Paragon 28's engineering and sales teams for real-time support and surgical planning insights. The system transforms these imaging inputs into 3D patient-specific case reports for preoperative planning. While specific details on integration with broader hospital EHR systems are not extensively covered, AI tools often require integration with existing healthcare IT infrastructure.
Paragon 28 offers educational programs such as the SMART28u2120 Advanced Technology Course, designed to immerse surgeons in patient-specific planning, imaging, and surgical execution for foot and ankle procedures, including PCFD. These courses integrate real surgeon-submitted cases, advanced imaging, 3D printing, and custom instrumentation, with faculty experts guiding participants through didactic sessions, interactive workshops, and cadaveric labs. The SMART28u2120 Case Management Portal also provides a direct line of communication with Paragon 28's engineering and sales teams for ongoing support.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20

Investors who backed SMART PCFD

Funded through the company that built this tool.

Greylock Partners
VC T1
Menlo Park, United States
$1M-$5M
Greylock is one of the oldest and most consistently top-quartile venture firms in the industry, with a portfolio that includes Facebook, LinkedIn,…
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