Spectral AI Announces Submission to FDA of its DeepView® System
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.
Spectral AI (NASDAQ: MDAI) ha presentato una domanda di autorizzazione commerciale De Novo 510k alla FDA per il suo sistema DeepView®, un dispositivo medico innovativo progettato per l'assistenza alle ustioni. Il sistema DeepView, che ha ricevuto la Designazione di Dispositivo Innovativo dalla FDA nel 2018, combina imaging multispettrale con algoritmi di intelligenza artificiale per prevedere il potenziale di guarigione delle ferite da ustione.
Il sistema fornisce previsioni di guarigione non invasive il giorno dell'infortunio e fino a 7 giorni dopo, permettendo ai medici di prendere decisioni terapeutiche più precoci e informate. Il percorso regolatorio De Novo è stato scelto per la natura innovativa della tecnologia, in quanto non esistono dispositivi simili sul mercato statunitense.
Lo sviluppo è stato supportato da fondi federali del Dipartimento della Salute e dei Servizi Umani degli Stati Uniti, dell'Amministrazione per la Preparazione Strategica e la Risposta e BARDA, attraverso diversi contratti dal 2013, con il numero di contratto attuale 75A50123C00049.
Spectral AI (NASDAQ: MDAI) ha presentado una solicitud de autorización comercial De Novo 510k a la FDA para su sistema DeepView®, un dispositivo médico revolucionario diseñado para entornos de cuidado de quemaduras. El sistema DeepView, que recibió la Designación de Dispositivo Innovador de la FDA en 2018, combina imágenes multiespectrales con algoritmos de inteligencia artificial para predecir el potencial de curación de heridas por quemaduras.
El sistema ofrece predicciones de curación no invasivas desde el día de la lesión y hasta 7 días después, permitiendo a los clínicos tomar decisiones de tratamiento más tempranas e informadas. Se eligió la vía regulatoria De Novo debido a la naturaleza novedosa de la tecnología, ya que no existe un dispositivo similar en el mercado estadounidense.
El desarrollo ha sido apoyado con fondos federales del Departamento de Salud y Servicios Humanos de EE. UU., la Administración para la Preparación Estratégica y Respuesta, y BARDA mediante múltiples contratos desde 2013, siendo el número de contrato actual 75A50123C00049.
Spectral AI (NASDAQ: MDAI)는 화상 치료 환경을 위한 혁신적인 의료기기인 DeepView® 시스템에 대해 FDA에 De Novo 510k 마케팅 승인 신청을 제출했습니다. DeepView 시스템은 2018년에 FDA 혁신 의료기기 지정(Breakthrough Device Designation)을 받았으며, 다중 스펙트럼 영상과 AI 알고리즘을 결합하여 화상 상처 치유 가능성을 예측합니다.
이 시스템은 부상 당일과 부상 후 최대 7일까지 비침습적 치유 예측을 제공하여 임상의가 보다 빠르고 정확한 치료 결정을 내릴 수 있도록 돕습니다. 미국 시장에 유사한 선행 기기가 없기 때문에 기술의 혁신성을 고려하여 De Novo 규제 경로를 선택했습니다.
이 개발은 2013년부터 미국 보건복지부, 전략적 대비 및 대응 행정국, BARDA의 여러 계약을 통해 연방 자금 지원을 받아 진행되었으며, 현재 계약 번호는 75A50123C00049입니다.
Spectral AI (NASDAQ : MDAI) a soumis une demande d'autorisation de mise sur le marché De Novo 510k à la FDA pour son système DeepView®, un dispositif médical révolutionnaire conçu pour les soins des brûlures. Le système DeepView, qui a reçu la désignation de dispositif innovant de la FDA en 2018, combine imagerie multispectrale et algorithmes d'intelligence artificielle pour prédire le potentiel de cicatrisation des brûlures.
Le système fournit des prédictions de cicatrisation non invasives dès le jour de la blessure et jusqu'à 7 jours après, permettant aux cliniciens de prendre des décisions de traitement plus précoces et mieux informées. La voie réglementaire De Novo a été choisie en raison de la nature innovante de la technologie, aucun dispositif similaire n'existant sur le marché américain.
Le développement a été soutenu par des fonds fédéraux du Département de la Santé et des Services sociaux des États-Unis, de l'Administration pour la Préparation Stratégique et la Réponse, ainsi que de BARDA, via plusieurs contrats depuis 2013, le numéro de contrat actuel étant 75A50123C00049.
Spectral AI (NASDAQ: MDAI) hat bei der FDA eine De Novo 510k-Marktzulassungsanmeldung für sein DeepView®-System eingereicht, ein bahnbrechendes medizinisches Gerät für die Versorgung von Brandverletzungen. Das DeepView-System, das 2018 die FDA Breakthrough Device Designation erhielt, kombiniert multispektrale Bildgebung mit KI-Algorithmen, um das Heilungspotenzial von Brandwunden vorherzusagen.
Das System liefert nicht-invasive Heilungsprognosen am Tag der Verletzung und bis zu 7 Tage danach, wodurch Kliniker frühere und fundiertere Behandlungsentscheidungen treffen können. Der De Novo-Zulassungsweg wurde aufgrund der neuartigen Technologie gewählt, da kein vergleichbares Gerät auf dem US-Markt existiert.
Die Entwicklung wurde durch Bundesmittel des US-Gesundheitsministeriums, der Administration für Strategische Vorbereitung und Reaktion sowie BARDA unterstützt, mit mehreren Vertragsvergaben seit 2013. Die aktuelle Vertragsnummer lautet 75A50123C00049.
- 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
- 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.
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FAQ
What is the DeepView System by Spectral AI (NASDAQ: MDAI)?
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