SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM

by Spectral AI, Inc.  · Based in United States → — Seeing the Unknown®: Predictive AI for Faster, More Accurate Wound Care Decisions
Dermatology General Surgery Plastic Surgery

Contact for pricing
Regulatory Status Disclosed

Overview

The Spectral AI DeepView Wound Imaging System is an advanced, non-invasive diagnostic platform that leverages multispectral imaging and proprietary artificial intelligence (AI) algorithms to provide clinicians with immediate, objective insights into wound healing potential. Designed to visualize tissue characteristics not visible to the human eye, the DeepView System assists healthcare professionals in making faster and more accurate treatment decisions for various wound types.

The system captures images across visible and near-infrared light wavelengths to analyze tissue viability and blood perfusion. Its AI algorithms integrate image and clinical data, comparing it against a robust, clinically validated database (including the world’s largest burn biopsy tissue database) to predict healing outcomes. This technology offers a ‘Day One’ healing assessment, providing a simple ‘Yes/No’ prediction of whether a wound will heal or require surgical intervention, thereby guiding therapeutic procedures and optimizing patient care pathways.

Initially developed as a medical countermeasure for mass casualty events, the DeepView System is now applied in everyday clinical settings. It is a portable imaging platform with a user-friendly touch-screen display, designed for ease of use across various healthcare environments. The system aims to transform wound care management by improving diagnostic accuracy, reducing unnecessary procedures, and streamlining workflows for both acute and chronic wounds.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Multispectral imaging technology
  • Proprietary AI algorithms for wound healing prediction
  • Non-invasive and radiation-free imaging
  • Real-time, objective wound assessment
  • Diagnostic 'Day One' healing assessment
  • Rapid image acquisition (approx. 2 seconds)
  • Portable imaging platform
  • EHR connectivity option
  • Digital wound assessment and documentation
  • Trained on extensive clinical burn database

Use Cases

  • Burn wound assessment and triage
  • Diabetic foot ulcer healing prediction
  • Chronic wound management
  • Acute wound care decision support
  • Plastic and reconstructive surgery planning
  • Assessment of tissue blood perfusion

Details

Category Dermatology AI, Radiology & Imaging AI
Pricing Contact for pricing
  • Contact for pricing; Predicted tiers: initial device sale; annual licensing fee for physical and database maintenance; per-use fee
DeploymentPortable imaging platform with cloud-based data pipeline
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The DeepView System 2.0 received 510(k) clearance (K163339) on August 17, 2017, for studies of blood flow in microcirculation and various wound types. It also received FDA Breakthrough Device Designation in 2018 for its burn indication, and a De Novo 510(k) marketing clearance application for burn diagnosis was submitted in June 2025.

Integrations
EHR Not specified
Specialties Dermatology, General Surgery, Plastic Surgery

What the Web Says

The SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM is a non-invasive, AI-driven multispectral imaging device designed to predict wound healing potential for burns and diabetic foot ulcers. It aims to provide immediate and objective assessments, assisting clinicians in making informed treatment decisions and potentially improving patient outcomes while reducing healthcare costs. The system has demonstrated superior accuracy in identifying non-healing tissue compared to traditional physician assessments in burn validation studies.

Overall: Positive

Strengths

  • Outperforms physician judgment in identifying non-healing burn tissue, with significantly higher sensitivity.
  • Provides immediate and objective predictions of wound healing potential.
  • Non-invasive and cart-based for mobility within healthcare settings.
  • Utilizes AI algorithms trained on a vast proprietary database of clinically validated data points.
  • Potential to reduce infection rates and hospital readmissions by enabling earlier intervention.
  • Aims to improve patient care and reduce healthcare costs.

Limitations

  • Physicians showed higher specificity in identifying true negatives in burn assessments.
  • Not yet widely adopted, with early adoption in hospitals potentially taking time.
  • Limited long-term outcome data currently available.
  • No established pricing structure yet.
  • Currently validated primarily for thermal burns, though studies for diabetic foot ulcers are ongoing.
  • One Reddit discussion mentioned a pilot study where Laser Doppler Imaging (LDI) showed superior accuracy in predicting burn outcomes compared to DeepView's multispectral imaging.

Based on reviews from: MedTech Dive, Reddit, Elion, GlobeNewswire, Business Wire, AWS, Medical Device Network, RCSI University of Medicine and Health Sciences, YouTube, HealthAidb, SmartTRAK Blog, frog, part of Capgemini Invent

Last updated: 2026-07-19

Ratings & Reviews

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Press & Coverage

Medical Product Outsourcing
FDA Grants De Novo OK to Spectral AI's DeepView System - Medical Product Outsourcing
Spectral AI received U.S. Food and Drug Administration (FDA) de novo classification for its DeepView system, a non-invasive, predictive device that combines multispectral imaging with AI to evaluate burn wound healing potential. This classification allows the company to begin commercial distribution in the U.S. for use in various burn care settings.
2026-05
Spectral AI Investor Relations
Spectral AI Announces Submission to FDA of its DeepViewu00ae System
Spectral AI announced the submission of its De Novo 510k marketing clearance application to the FDA for the DeepView System, intended for use in burn care settings. The system, which received Breakthrough Device Designation in 2018, uses multi-spectral imaging and AI to predict burn healing potential.
2025-06
Pluang
Spectral AI's DeepView System gains FDA clearance, aiding faster burn wound treatment decisions - Pluang
Spectral AI's DeepView System received FDA De Novo Classification in May 2026, allowing for faster and more precise treatment decisions for burn wounds. This non-invasive system uses multispectral imaging and AI to identify burn areas unlikely to heal within 21 days, aiming to improve patient outcomes and reduce healthcare costs.
2026-06
Zacks Small Cap Research
MDAI: DeepView FDA Clearance Fires Up Our Valuation - Zacks Small Cap Research
Following the FDA De Novo clearance for its DeepView Burn diagnostic in May 2026, Zacks Small Cap Research increased its valuation for Spectral AI. The company's focus will now shift to commercialization and clinical trial efforts, with plans to deploy units in the United States, Europe, Australia, and the Middle East.
2026-06
MedTech Dive
Spectral AI algorithms beat physicians in burn tissue assessments | MedTech Dive
Spectral AI's DeepView System demonstrated superior performance over burn physicians in identifying non-healing tissue in a burn validation study. The system achieved significantly higher sensitivity in both image-wise and pixel-wise assessments, with the company planning to file these results with the FDA by mid-2025.
2025-03
Spectral AI Investor Relations
Spectral AI Announces Last Patient Out in U.S. Burn Pivotal Study at Burn Centers
Spectral AI announced the completion of patient clinical visits in its U.S. Burn Pivotal Study, a significant milestone before seeking FDA approval for its DeepViewu00ae System for burn indication in the first half of 2025. The study aims to validate the AI-driven device's ability to distinguish between healing and non-healing tissue.
2024-10
Clinical Trials Arena
Spectral AI adds three southern US sites to AI burn assessment study - Clinical Trials Arena
Spectral AI expanded its US pivotal study for the DeepView AI-based diagnostics platform by adding three new clinical trial sites in Texas, Florida, and Alabama. This brings the total number of locations to 16, moving the company closer to completing the 2024 Burn Pivotal Study and seeking FDA approval in 2025.
2024-07
The Open Public Health Journal
The Progress and Future of Artificial Intelligence in Nursing Care: A Review - The Open Public Health Journal
The Spectral MD DeepView Wound Imaging System is highlighted in a review article on AI in nursing care for its ability to provide images of blood flow in microcirculation and assess perfusion of healthy and injured skin. This technology plays an important role in wound care, including burns, chronic wounds, and diabetic ulcers.
2024-05

Videos

Product demos, reviews, and walkthroughs for SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM.

View all on YouTube

Frequently Asked Questions

The DeepView AIu00ae System is an AI-based wound assessment and imaging platform designed to provide non-invasive, real-time predictions of wound healing potential, primarily for thermal burn wounds and diabetic foot ulcers. It assists healthcare providers in making faster, more informed treatment decisions by offering objective insights into tissue viability that are not visible to the human eye, thereby reducing diagnostic uncertainty.
In studies, the DeepView AIu00ae System has demonstrated consistent predictability of burn wound healing potential, outperforming traditional clinical judgment in identifying non-healing tissue with 86.6% sensitivity compared to 40.8% for physicians. While Laser Doppler Imaging (LDI) is another technology for burn outcome prediction, DeepView utilizes multispectral imaging and AI algorithms for its assessments.
Spectral AI has received ISO 13485 certification for the manufacture and distribution of its DeepViewu00ae Wound Imaging System, ensuring high standards of quality and safety. The system also received Breakthrough Device Designation from the U.S. FDA in 2018 for its burn indication, and the company is pursuing a De Novo submission for Class II medical device classification, expected in Q2 2025.
The DeepView AIu00ae System is currently indicated for thermal burn wounds, though it is also being validated for diabetic foot ulcers. While it shows high sensitivity in identifying non-healing tissue, one study noted lower specificity compared to physician assessments, which may reflect a more conservative approach by clinicians.
Speculative estimates suggest an annual cost per site ranging from $50,000 to $100,000. This includes an estimated device cost of $30,000-$50,000 annually for a lease/subscription covering hardware, support, and maintenance, plus an additional $20,000-$50,000 annually for AI algorithms, burn database access, and software enhancements.
Before scanning, all dressings and topical agents must be removed from the wound area. Standard wound cleansing protocols should be followed, and any loose skin, blisters, or debris should be thoroughly cleaned.
Yes, the DeepView System offers an option for EHR connectivity. This allows for the integration of objective, standardized wound assessment data into patient records, supporting streamlined clinical documentation and workflows.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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