FIREFLY Technology

JSON twin: https://www.healthaidb.com/software/firefly-technology.json

Company Name

Mighty Oak Medical

Product URL

https://mightyoakmedical.com/firefly

Company URL

https://mightyoakmedical.com

Categories

• clinical Care
• diagnostic Support
• surgical Navigation
• clinical Decision Support
• imaging Software
• surgical Care
• surgical Planning
• radiation Therapy
• financial Analytics
• Clinical
• Diagnostic
• Patient-specific Solutions
• 3d Printing
• Spinal Surgery
• Pre-surgical Planning
• Anatomical Modeling
• Radiation Reduction
• Cost Efficiency

Summary

FIREFLY Technology by Mighty Oak Medical offers patient-specific, 3D printed navigation guides to enhance accuracy and safety in spinal surgeries.

Description

FIREFLY Technology provides a comprehensive solution for spinal surgery by delivering customized pre-surgical planning, patient-specific 3D printed navigation guides, and anatomical models. This approach aims to improve surgical precision, reduce radiation exposure, and decrease operating time and costs. The system is compatible with various pedicle screw systems, offering versatility for surgeons. Additionally, the technology has been FDA-cleared and is utilized in both adult and pediatric spinal procedures, including complex deformity cases and scoliosis treatments.

Api Available

no

Certifications

• FDA 510(k) clearance

Company Founding

2011

Company Offices

• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Japan
• China
• India
• Australia

Compliance

• HIPAA
• ISO 27001
• SOC 2 Type II
• GDPR

Customers

• Shriners Children’s Southern California
• Virginia Mason Medical Center
• Restore Orthopedics and Spine Center
• Cleveland Clinic

Data Residency

US-only

Data Standards

• DICOM

Deployment Model

• on_prem

Features

• Patient-specific 3D printed pedicle screw navigation guides
• Pre-surgical planning with predictive implant sizes and trajectories
• Open platform compatible with various pedicle screw systems
• Reduced intraoperative radiation exposure
• Enhanced surgical accuracy and efficiency
• Pediatric scoliosis surgical solutions
• Multi-level, uni-lateral, and bi-lateral guide options
• Autoclavable bone models for preoperative evaluation and intraoperative reference

Id

SW0197

Integration Partners

• HP
• Spinal Elements

Integrations

• Various pedicle screw systems

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Portuguese
• Dutch
• Russian
• Chinese
• Japanese

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• Midline Navigation Guides
• S2-AI Navigation Guides

Os Platforms

• Windows
• macOS
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• Data anonymization
• Data minimization

Product Code

SW0197

Product Name

FIREFLY Technology

Ratings

• FDA clearance for patient-specific 3D-printed navigation guides
• FDA clearance for S2AI Guide for sacroiliac fixation
• CE-mark for 3D printed medical models and surgical guides
• FDA clearance for compatibility with all currently cleared pedicle screw systems
• FDA clearance for use in pediatric patients
• FDA clearance for T1-S2/ilium indications
• FDA clearance for single-use and scalable system
• FDA clearance for open platform compatibility
• FDA clearance for reduced intraoperative radiation exposure
• FDA clearance for improved OR efficiency

Regions Available

• United States
• Europe
• Asia
• Australia
• Canada
• South America
• Africa
• Middle East
• India
• China

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

2016

Security Features

• Data encryption in transit and at rest
• Access controls
• Audit trails

Specialties

• Spinal Surgery
• Orthopedics
• Pediatric Orthopedics
• Scoliosis Treatment
• Complex Spinal Deformities

Support Channels

• email
• phone
• chat
• ticketing
• community
• 24x7

System Requirements

Windows, macOS, Linux

Target Users

• clinicians
• surgeons
• biomedical designers
• hospital staff
• pediatric orthopedic surgeons

Training Options

• documentation
• webinars
• live_online
• onsite
• certification

Type

product

User Reviews

• The FIREFLY system has been a game changer for my practice, allowing accurate preoperative planning and intraoperative navigated pedicle screw placement without the hassle or cost of a dedicated navigation system and intraoperative tomography device.
• FIREFLY has allowed me to tackle the most complex spinal deformity faster and with greater accuracy in placement of screws in rotated and atretic pedicles that I used to skip.
• I use FIREFLY Patient-Specific Guides in all of my complex cases. The presurgical planning that Mighty Oak does is superb, providing detailed analytics regarding each patient’s spinal anatomy.
• FIREFLY patient-specific, 3D printed drill guides have dramatically reduced surgical times while improving accuracy in pedicle screw placement in very complex anatomic situations. The anatomical models are also a significant value add for intraoperative decision making. FIREFLY has become an indispensable part of my toolkit for complex spine deformity surgery.

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "FIREFLY Technology",
  "company_name": "Mighty Oak Medical",
  "product_url": "https://mightyoakmedical.com/firefly",
  "company_url": "https://mightyoakmedical.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0197",
  "summary": "FIREFLY Technology by Mighty Oak Medical offers patient-specific, 3D printed navigation guides to enhance accuracy and safety in spinal surgeries.",
  "description": "FIREFLY Technology provides a comprehensive solution for spinal surgery by delivering customized pre-surgical planning, patient-specific 3D printed navigation guides, and anatomical models. This approach aims to improve surgical precision, reduce radiation exposure, and decrease operating time and costs. The system is compatible with various pedicle screw systems, offering versatility for surgeons. Additionally, the technology has been FDA-cleared and is utilized in both adult and pediatric spinal procedures, including complex deformity cases and scoliosis treatments.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "surgical Navigation",
    "clinical Decision Support",
    "imaging Software",
    "surgical Care",
    "surgical Planning",
    "radiation Therapy",
    "financial Analytics",
    "Clinical",
    "Diagnostic",
    "Surgical Navigation",
    "Patient-specific Solutions",
    "3d Printing",
    "Spinal Surgery",
    "Pre-surgical Planning",
    "Anatomical Modeling",
    "Radiation Reduction",
    "Cost Efficiency"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "clinicians",
    "surgeons",
    "biomedical designers",
    "hospital staff",
    "pediatric orthopedic surgeons"
  ],
  "specialties": [
    "Spinal Surgery",
    "Orthopedics",
    "Pediatric Orthopedics",
    "Scoliosis Treatment",
    "Complex Spinal Deformities"
  ],
  "regions_available": [
    "United States",
    "Europe",
    "Asia",
    "Australia",
    "Canada",
    "South America",
    "Africa",
    "Middle East",
    "India",
    "China"
  ],
  "languages_supported": [
    "English",
    "Spanish",
    "French",
    "German",
    "Italian",
    "Portuguese",
    "Dutch",
    "Russian",
    "Chinese",
    "Japanese"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States",
    "Germany",
    "France",
    "United Kingdom",
    "Italy",
    "Spain",
    "Japan",
    "China",
    "India",
    "Australia"
  ],
  "company_founding": "2011",
  "deployment_model": [
    "on_prem"
  ],
  "os_platforms": [
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Patient-specific 3D printed pedicle screw navigation guides",
    "Pre-surgical planning with predictive implant sizes and trajectories",
    "Open platform compatible with various pedicle screw systems",
    "Reduced intraoperative radiation exposure",
    "Enhanced surgical accuracy and efficiency",
    "Pediatric scoliosis surgical solutions",
    "Multi-level, uni-lateral, and bi-lateral guide options",
    "Autoclavable bone models for preoperative evaluation and intraoperative reference"
  ],
  "optional_modules": [
    "Midline Navigation Guides",
    "S2-AI Navigation Guides"
  ],
  "integrations": [
    "Various pedicle screw systems"
  ],
  "data_standards": [
    "DICOM"
  ],
  "api_available": "no",
  "system_requirements": "Windows, macOS, Linux",
  "compliance": [
    "HIPAA",
    "ISO 27001",
    "SOC 2 Type II",
    "GDPR"
  ],
  "certifications": [
    "FDA 510(k) clearance"
  ],
  "security_features": [
    "Data encryption in transit and at rest",
    "Access controls",
    "Audit trails"
  ],
  "privacy_features": [
    "Data anonymization",
    "Data minimization"
  ],
  "data_residency": "US-only",
  "customers": [
    "Shriners Children’s Southern California",
    "Virginia Mason Medical Center",
    "Restore Orthopedics and Spine Center",
    "Cleveland Clinic"
  ],
  "user_reviews": [
    "The FIREFLY system has been a game changer for my practice, allowing accurate preoperative planning and intraoperative navigated pedicle screw placement without the hassle or cost of a dedicated navigation system and intraoperative tomography device.",
    "FIREFLY has allowed me to tackle the most complex spinal deformity faster and with greater accuracy in placement of screws in rotated and atretic pedicles that I used to skip.",
    "I use FIREFLY Patient-Specific Guides in all of my complex cases. The presurgical planning that Mighty Oak does is superb, providing detailed analytics regarding each patient’s spinal anatomy.",
    "FIREFLY patient-specific, 3D printed drill guides have dramatically reduced surgical times while improving accuracy in pedicle screw placement in very complex anatomic situations. The anatomical models are also a significant value add for intraoperative decision making. FIREFLY has become an indispensable part of my toolkit for complex spine deformity surgery."
  ],
  "ratings": [
    "FDA clearance for patient-specific 3D-printed navigation guides",
    "FDA clearance for S2AI Guide for sacroiliac fixation",
    "CE-mark for 3D printed medical models and surgical guides",
    "FDA clearance for compatibility with all currently cleared pedicle screw systems",
    "FDA clearance for use in pediatric patients",
    "FDA clearance for T1-S2/ilium indications",
    "FDA clearance for single-use and scalable system",
    "FDA clearance for open platform compatibility",
    "FDA clearance for reduced intraoperative radiation exposure",
    "FDA clearance for improved OR efficiency"
  ],
  "support_channels": [
    "email",
    "phone",
    "chat",
    "ticketing",
    "community",
    "24x7"
  ],
  "training_options": [
    "documentation",
    "webinars",
    "live_online",
    "onsite",
    "certification"
  ],
  "release_year": "2016",
  "integration_partners": [
    "HP",
    "Spinal Elements"
  ],
  "id": "SW0197",
  "slug": "firefly-technology",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/firefly-technology.json"
  }
}