Spectral AI Highlights Unprecedented Collaboration with National Leaders in Burn Care for DeepView™ System Training and Validation Studies
Spectral AI (NASDAQ: MDAI) announced significant progress in the development of its DeepView® System, an AI-driven wound diagnostics platform. National burn care leaders have contributed over 511 in-person physician days for training and validation studies, plus 250 additional days in proof-of-concept studies. The collaboration includes three former/current presidents and ten board members of the American Burn Association, along with two editors-in-chief of leading burn journals.
The DeepView® System, which received FDA Breakthrough Device Designation in 2018 and UKCA mark for burn indications, combines advanced algorithms with medical imaging to predict wound healing potential. This unprecedented level of expert participation enhances the dataset's credibility and reliability, positioning DeepView® as a potential future standard in burn care diagnostics.
Spectral AI (NASDAQ: MDAI) ha annunciato progressi significativi nello sviluppo del suo DeepView® System, una piattaforma di diagnosi delle ferite basata su intelligenza artificiale. I leader nazionali della cura delle ustioni hanno contribuito con oltre 511 giorni di medici in presenza per studi di formazione e validazione, oltre a 250 giorni aggiuntivi per studi di prova di concetto. La collaborazione include tre ex/attuali presidenti e dieci membri del consiglio dell'American Burn Association, insieme a due editori in capo di importanti riviste sulle ustioni.
Il DeepView® System, che ha ricevuto la Designazione di Dispositivo Innovativo dalla FDA nel 2018 e il marchio UKCA per indicazioni relative alle ustioni, combina algoritmi avanzati con immagini mediche per prevedere il potenziale di guarigione delle ferite. Questo livello senza precedenti di partecipazione da parte degli esperti aumenta la credibilità e l'affidabilità del set di dati, posizionando il DeepView® come un potenziale standard futuro nella diagnostica delle ustioni.
Spectral AI (NASDAQ: MDAI) anunció avances significativos en el desarrollo de su DeepView® System, una plataforma de diagnóstico de heridas impulsada por inteligencia artificial. Líderes nacionales en el cuidado de quemaduras han contribuido con más de 511 días de médicos en persona para estudios de capacitación y validación, además de 250 días adicionales en estudios de prueba de concepto. La colaboración incluye a tres expresidentes/actuales y diez miembros de la junta de la American Burn Association, junto con dos editores en jefe de revistas de quemaduras líderes.
El DeepView® System, que recibió la designación de Dispositivo Innovador de la FDA en 2018 y la marca UKCA para indicaciones de quemaduras, combina algoritmos avanzados con imágenes médicas para predecir el potencial de cicatrización de heridas. Este nivel sin precedentes de participación de expertos mejora la credibilidad y fiabilidad del conjunto de datos, posicionando a DeepView® como un posible estándar futuro en el diagnóstico de quemaduras.
스펙트럴 AI (NASDAQ: MDAI)가 AI 기반 상처 진단 플랫폼인 DeepView® 시스템의 개발에 있어 중요한 진전을 발표했습니다. 국가 화상 치료 전문가들은 교육 및 검증 연구를 위해 511일 이상의 현장 의사 Days 기여했으며, 250일은 개념 증명 연구에 추가로 제공했습니다. 이 협력에는 미국 화상 협회의 전/현직 회장 3명과 이사회 구성원 10명, 그리고 주요 화상 저널의 편집장 2명이 포함됩니다.
2018년에 FDA의 혁신적인 장치 지정과 화상 관련 UKCA 마크를 받은 DeepView® 시스템은 고급 알고리즘과 의료 이미징을 결합하여 상처 치유 가능성을 예측합니다. 전문가 참여의 이 전례 없는 수준은 데이터 세트의 신뢰성과 신뢰성을 향상시키며, DeepView®를 화상 치료 진단의 잠재적 미래 표준으로 자리매김합니다.
Spectral AI (NASDAQ: MDAI) a annoncé des avancées significatives dans le développement de son Système DeepView®, une plateforme de diagnostic des blessures basée sur l'intelligence artificielle. Des leaders nationaux des soins des brûlures ont contribué avec plus de 511 jours de médecins en personne pour des études de formation et de validation, ainsi que 250 jours supplémentaires pour des études de faisabilité. La collaboration comprend trois anciens/actuels présidents et dix membres du conseil d'administration de l'American Burn Association, ainsi que deux rédacteurs en chef de revues sur les brûlures de premier plan.
Le Système DeepView®, qui a reçu la désignation Dispositif Breakthrough de la FDA en 2018 et le marquage UKCA pour les indications de brûlures, combine des algorithmes avancés avec l'imagerie médicale pour prédire le potentiel de guérison des blessures. Ce niveau sans précédent de participation des experts améliore la crédibilité et la fiabilité des données, positionnant DeepView® comme un potentiel futur standard dans le diagnostic des brûlures.
Spectral AI (NASDAQ: MDAI) hat erhebliche Fortschritte in der Entwicklung seines DeepView® Systems angekündigt, einer KI-gesteuerten Plattform zur Wunddiagnose. Nationale Führungspersönlichkeiten im Bereich Brandverletzungen haben über 511 Tage mit Ärzten vor Ort für Trainings- und Validierungsstudien beigetragen, zusätzlich zu 250 weiteren Tagen in Machbarkeitsstudien. Die Zusammenarbeit umfasst drei ehemalige/aktuelle Präsidenten und zehn Vorstandsmitglieder der American Burn Association sowie zwei Chefredakteure führender Verbrennungsmagazine.
Das DeepView® System, das 2018 die Zulassung als Durchbruch-Gerät von der FDA erhielt und das UKCA-Zeichen für Brandindikationen trägt, kombiniert fortschrittliche Algorithmen mit medizinischer Bildgebung, um das Heilungspotenzial von Wunden vorherzusagen. Dieses beispiellose Maß an Expertenbeteiligung erhöht die Glaubwürdigkeit und Zuverlässigkeit des Datensatzes und positioniert DeepView® als potenziellen zukünftigen Standard in der Diagnose von Brandverletzungen.
- Secured extensive collaboration with leading burn care experts (511+ physician days)
- Received FDA Breakthrough Device Designation in 2018
- Obtained UKCA mark for burn indications
- High-profile expert participation including 3 presidents and 10 board members of American Burn Association
- None.
Insights
This collaboration represents a significant milestone in AI-driven medical diagnostics validation. The engagement of 511 in-person physician days plus 250 additional days for proof-of-concept studies demonstrates unprecedented clinical commitment. The involvement of three former ABA presidents and ten board members adds substantial credibility to DeepView's development process.
The FDA Breakthrough Device Designation from 2018, combined with the recent UKCA mark, suggests a strong regulatory pathway. However, it's important to note that while this collaboration is impressive, the timeline to full FDA approval and market penetration remains unclear. The extensive validation process could accelerate FDA review but doesn't guarantee immediate commercial success.
The DeepView System's AI algorithm development benefits significantly from this extensive clinical collaboration. Having top burn care experts actively participate in training the AI creates a highly specialized and validated dataset, which is important for medical AI systems. The combination of multispectral imaging with expert-trained algorithms could provide a competitive advantage in wound diagnostics.
The technology's ability to predict wound healing potential addresses a critical clinical need, potentially reducing subjective assessments in burn care. The extensive physician involvement in algorithm training suggests a robust validation process that could lead to higher accuracy and clinical acceptance.
DALLAS, Dec. 12, 2024 (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. FDA in 2018, that uses multi-spectral imaging and algorithms to predict burn healing potential, today announced that national leaders in burn care have dedicated more than an estimated 511 in-person days of physician engagement to the training and validation studies for the DeepView™ System for U.S. Food and Drug Administration (FDA) submission. This does not include more than an estimated 250 additional days that these experts devoted in Proof-of-Concept studies.
This extraordinary collaboration includes participation from physicians across the country who are national leaders in burn care. They include three current or former presidents, and ten board members/past board members of the national burn organization, the American Burn Association, and two editors-in-chief of leading medical burn journals. This level of participation by such esteemed professionals represents an unprecedented investment of time and expertise to work with Spectral AI’s team to develop artificial intelligence algorithm.
Spectral AI’s patented DeepView® technology is an AI-driven wound diagnostics platform that combines advanced algorithms with medical imaging to predict wound healing potential that has been Breakthrough Designated by the FDA. The platform relies on a specialized dataset, allowing it to identify critical patterns and deliver compelling clinical insights. This unique collaboration with a world-class team of burn experts enhances the dataset's credibility and reliability as well as underscores the study's groundbreaking nature.
“This level of cooperation represents an unprecedented amount of time and effort for national leaders in burn care,” said Dr. Jeffrey Carter, M.D., Principal Investigator of the studies. “We are deeply grateful for the leadership of Dr. Michael DiMaio and the engagement of this exceptional group of clinicians.”
Dr. Michael DiMaio, Chairman of Spectral AI’s board of directors, added, “I am extremely proud of our Spectral AI team and the fact that we have been able to include some of our country’s most highly regarded burn experts in DeepView’s training and validation study. These experts allow the algorithm to be trained by the best-in-class clinicians with countless years of experience. This joint effort reflects our unwavering commitment to ensuring the DeepView® System becomes a gold-standard tool in burn care.”
DeepView® received a significant endorsement in 2018 when it was granted the Breakthrough Device Designation from the U.S. FDA. This recognition, coupled with the achievement of the United Kingdom Conformity Assessed (UKCA) mark for burn indications earlier this year, positions DeepView® as a potential game-changer in medical diagnostics.
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 and diabetic foot ulcers. The Company is working to revolutionize the management of wound care by “Seeing the Unknown®” with its DeepView® System. DeepView is a predictive device that offers clinicians an objective and immediate assessment of a 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, DeepView is expected to provide faster and more accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs. For more information about DeepView, 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 intention to separate its Spectral IP subsidiary from the Company, and each Company’s strategy, plans, objectives, initiatives, strategic goals, financial outlook or other non-historical matters. 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. Spectral AI undertakes no obligation to update any forward-looking statements except as otherwise required by law.
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FAQ
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