Spectral AI Announces Submission to FDA of its DeepView® System
Rhea-AI Summary
Spectral AI (NASDAQ: MDAI) has submitted a De Novo 510k marketing clearance application to the FDA for its DeepView® System, a breakthrough medical device designed for burn care settings. The DeepView System, which received FDA Breakthrough Device Designation in 2018, combines multi-spectral imaging with AI algorithms to predict burn wound healing potential.
The system provides non-invasive healing predictions on the day of injury and up to 7 days post-injury, enabling clinicians to make earlier and more informed treatment decisions. The De Novo regulatory pathway was chosen due to the technology's novel nature, as no predicate device exists in the U.S. market.
The development has been supported by federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, and BARDA through multiple contract awards since 2013, with the current contract number being 75A50123C00049.
Positive
- FDA submission represents significant regulatory progress for novel medical device
- Technology provides same-day and up to 7-day post-injury healing predictions
- System offers non-invasive assessment method for burn wounds
- Continued federal funding support through BARDA contracts since 2013
- Previously received FDA Breakthrough Device Designation in 2018
Negative
- No current market approval - still pending FDA review
- No predicate device in U.S. market, which may extend regulatory timeline
Insights
Spectral AI's FDA De Novo submission for its DeepView burn assessment system marks a critical regulatory milestone toward commercialization.
Spectral AI has reached a significant regulatory milestone with its De Novo 510(k) submission to the FDA for the DeepView System, an AI-powered diagnostic tool for burn assessment. This submission represents a crucial step toward potential commercialization in the US market, following the technology's earlier Breakthrough Device Designation in 2018.
The regulatory pathway chosen is particularly noteworthy. The De Novo classification is specifically designed for novel medical devices without existing predicates on the market. This confirms the innovative nature of Spectral's technology but also means the FDA review process will be more rigorous than a traditional 510(k) submission.
The technology itself addresses a critical clinical need in burn care: the ability to assess healing potential on the day of injury and up to 7 days post-injury. Current standard assessment methods often require waiting days or weeks to determine whether a burn will heal naturally or require surgical intervention. The DeepView System's potential to provide this assessment immediately could significantly impact treatment decisions, potentially reducing unnecessary surgeries while ensuring timely interventions when needed.
The federal funding support from BARDA (Biomedical Advanced Research and Development Authority) through multiple contracts since 2013 is also significant, indicating sustained government interest in this technology for emergency preparedness applications. This funding relationship suggests the technology has potential applications beyond routine clinical care, possibly including mass casualty scenarios.
While this submission is a positive step, investors should note that the De Novo pathway typically involves longer review timelines than standard 510(k) clearances, often taking 9-12 months or more. The company now enters a critical waiting period as the FDA evaluates this novel technology.
DALLAS, June 30, 2025 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView® System, which received Breakthrough Device Designation from the U.S. Food and Drug Administration (“FDA”) in 2018 and uses multi-spectral imaging and artificial intelligence (“AI”) algorithms to predict burn healing potential, today 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, including both burn centers and emergency departments. The De Novo regulatory pathway is being pursued due to the novel nature of this technology, which does not have a predicate device currently available in the U.S. market.
Spectral AI's DeepView System is a non-invasive, predictive medical device and associated software platform that combines multispectral imaging with a proprietary AI algorithm to assess the healing potential of burn wounds. The DeepView System provides clinicians with a non-healing prediction—on the same day of injury and up to a week (7 days) post injury, enabling earlier and more informed treatment decisions.
“This FDA submission is a major milestone for Spectral AI and the DeepView System, representing a crucial step toward bringing this innovative diagnostic device to market in the United States. It provides clinicians with an immediate, data-driven assessment tool designed to assist clinical decision-making and may significantly improve patient outcomes,” stated Dr. J. Michael DiMaio, MD, Chairman of the Board at Spectral AI. “I am grateful to our shareholders for their continued support as we reach this important milestone in submitting the De Novo request to the FDA for the DeepView System,” DiMaio said. “I am also incredibly proud of our team’s dedication and remain confident in our mission to bring this technology to the broader healthcare market worldwide.”
This project is being supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under contract number 75A50123C00049 with its wholly-owned subsidiary Spectral MD, Inc. Since 2013 and prior to this contract, the advance development of this technology has been supported in two previous contract awards under contract numbers 75A50119C00033 and HHSO100201300022C.
About Spectral AI
Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns. The Company is working to revolutionize the management of wound care by “Seeing the Unknown®” with its DeepView System. The DeepView System is being developed as a predictive device to offer clinicians an objective and immediate assessment of a burn wound’s healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal of exceeding the current standard of care in the future, the DeepView System is expected to provide fast and accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs. For more information about the DeepView System, visit www.spectral-ai.com.
Forward-Looking Statements
Certain statements made in this release are “forward looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s strategy, plans, objectives, initiatives and financial outlook. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “may,” “will,” “should,” “future,” “propose” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, readers are cautioned not to place undue reliance on any forward-looking statements.
Investors should carefully consider the foregoing factors, and the other risks and uncertainties described in the “Risk Factors” sections of the Company’s filings with the SEC, including the Registration Statement and the other documents filed by the Company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.
For Media and Investor Relations, please contact:
David Kugelman
Atlanta Capital Partners LLC
(866) 692-6847 Toll Free - U.S. & Canada
(404) 281-8556 Mobile and WhatsApp
Email: dk@atlcp.com
FAQ
What is the DeepView System by Spectral AI (NASDAQ: MDAI)?
What type of FDA application did Spectral AI submit for the DeepView System?
How quickly can the DeepView System predict burn wound healing?
When did Spectral AI's DeepView System receive FDA Breakthrough Device Designation?
Who is funding the development of Spectral AI's DeepView System?
