Spectral AI Completes Truthing of Burn Center Images, Initiates Emergency Department Image Review
Spectral AI (NASDAQ: MDAI) has completed the truthing process for all burn center images across the US, a important step in training its DeepView® System for wound healing prediction. The company is now expanding to emergency department image review. The truthing process involves gathering 'ground truth' data through early treatment images, biopsies, 21-day assessments, and expert evaluations. The company has assembled over 3,000 biopsied images in its tissue dataset. Having completed enrollment and image collection for the BARDA burn study, Spectral AI expects data results in late December to support an FDA De Novo submission in H1 2025, aiming for Class II medical device classification for the DeepView AI®-Burn system.
Spectral AI (NASDAQ: MDAI) ha completato il processo di verifica per tutte le immagini dei centri ustionati negli Stati Uniti, un passo importante nella formazione del suo DeepView® System per la previsione della guarigione delle ferite. L'azienda sta ora espandendo la revisione delle immagini nel dipartimento di emergenza. Il processo di verifica prevede la raccolta di dati di 'verità di base' attraverso immagini di trattamenti precoci, biopsie, valutazioni a 21 giorni e valutazioni da esperti. L'azienda ha assemblato oltre 3.000 immagini biopsiate nel suo dataset tissutale. Dopo aver completato l'iscrizione e la raccolta delle immagini per lo studio sulle ustioni BARDA, Spectral AI prevede risultati dei dati a fine dicembre per supportare una submission De Novo alla FDA nel primo semestre del 2025, mirando alla classificazione come dispositivo medico di Classe II per il sistema DeepView AI®-Burn.
Spectral AI (NASDAQ: MDAI) ha completado el proceso de verificación para todas las imágenes de los centros de quemados en los EE. UU., un paso importante en el entrenamiento de su DeepView® System para la predicción de la curación de heridas. La empresa ahora está expandiéndose a la revisión de imágenes en el departamento de emergencias. El proceso de verificación implica la recopilación de datos de 'verdad básica' a través de imágenes de tratamientos tempranos, biopsias, evaluaciones a 21 días y evaluaciones de expertos. La empresa ha reunido más de 3,000 imágenes biopsiadas en su conjunto de datos de tejidos. Tras haber completado el registro y la recolección de imágenes para el estudio de quemaduras BARDA, Spectral AI espera resultados de datos a finales de diciembre para respaldar una presentación De Novo ante la FDA en el primer semestre de 2025, con el objetivo de clasificar el sistema DeepView AI®-Burn como dispositivo médico de Clase II.
Spectral AI (NASDAQ: MDAI)는 미국 전역의 화상 센터 이미지에 대한 진실화 과정을 완료했습니다. 이는 DeepView® System의 상처 치유 예측 훈련에 중요한 단계입니다. 회사는 이제 응급실 이미지 검토로 확장하고 있습니다. 진실화 과정은 조기 치료 이미지, 생검, 21일 평가 및 전문가 평가를 통해 '기초 진실' 데이터를 수집하는 것을 포함합니다. 회사는 조직 데이터 세트에서 3,000개 이상의 생검 이미지를 모았습니다. BARDA 화상 연구를 위한 등록 및 이미지 수집을 완료한 후, Spectral AI는 2025년 상반기에 FDA De Novo 제출을 지원하기 위해 12월 말에 데이터 결과를 기대하고 있으며, DeepView AI®-Burn 시스템에 대한 클래스 II 의료기기 분류를 목표로 하고 있습니다.
Spectral AI (NASDAQ: MDAI) a terminé le processus de validation pour toutes les images des centres de brûlures aux États-Unis, une étape importante dans la formation de son Système DeepView® pour la prévision de la cicatrisation des plaies. L'entreprise s'étend maintenant à la révision des images dans les services d'urgence. Le processus de validation implique la collecte de données de 'vérité de terrain' à travers des images de traitements précoces, des biopsies, des évaluations à 21 jours et des évaluations par des experts. L'entreprise a rassemblé plus de 3 000 images biopsiées dans son ensemble de données tissulaires. Après avoir complété l'inscription et la collecte d'images pour l'étude sur les brûlures BARDA, Spectral AI s'attend à des résultats de données fin décembre pour soutenir une soumission De Novo à la FDA au premier semestre 2025, visant à la classification en tant que dispositif médical de Classe II pour le système DeepView AI®-Burn.
Spectral AI (NASDAQ: MDAI) hat den Verifizierungsprozess für alle Bilder von Brandzentren in den USA abgeschlossen, ein wichtiger Schritt zur Schulung seines DeepView® Systems zur Vorhersage der Wundheilung. Das Unternehmen erweitert nun die Bildüberprüfung in der Notaufnahme. Der Verifizierungsprozess beinhaltet das Sammeln von 'Ground Truth'-Daten durch frühe Behandlungsbilder, Biopsien, 21-tägige Bewertungen und Expertenbewertungen. Das Unternehmen hat über 3.000 bioptische Bilder in seinem Gewebedatensatz zusammengestellt. Nachdem die Einschreibung und die Bilderfassung für die BARDA-Verbrennungsstudie abgeschlossen wurden, erwartet Spectral AI Ende Dezember Daten Ergebnisse zur Unterstützung einer FDA De Novo-Einreichung im ersten Halbjahr 2025, mit dem Ziel, das DeepView AI®-Burn-System als Medizinprodukt der Klasse II zu klassifizieren.
- Successfully completed truthing process for burn center images, expanding dataset to over 3,000 biopsied images
- Completed enrollment and image collection for BARDA burn study
- On track for FDA De Novo submission in first half of 2025
- None.
Insights
The completion of burn center image truthing represents significant progress in Spectral AI's development of the DeepView® System. With over 3,000 biopsied images, this is the largest burn tissue dataset of its kind. The expansion into emergency department data collection will further enhance the system's capabilities across different clinical settings.
The anticipated FDA De Novo submission in H1 2025 is a important regulatory milestone. If successful in achieving Class II medical device classification, it would validate the technology's safety and effectiveness while potentially opening significant market opportunities. The BARDA burn study completion adds credibility to the submission process.
The system's ability to provide rapid burn-depth assessments could significantly improve treatment decision-making efficiency and patient outcomes. However, investors should note that regulatory approval timelines can be unpredictable and market adoption will depend on clinical validation and healthcare provider acceptance.
DALLAS, Dec. 02, 2024 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on revolutionizing medical diagnostics to enable faster, more accurate treatment decisions in wound care, today announced the successful completion of truthing for all images gathered from burn centers across the United States. This milestone represents a pivotal step in training the Company's proprietary DeepView® System to predict wound healing outcomes accurately. Having completed the process for burn centers, Spectral AI is now initiating truthing for images collected from emergency departments and emergency rooms nationwide, expanding the scope of the DeepView® System's capabilities.
Truthing is the rigorous process of gathering ‘ground truth’ data that verifies whether portions of a wound did or did not heal and then using this data for training of its AI-powered algorithm. For each patient, images are collected during the early stages of treatment and correlated with biopsies, 21-day wound assessments, and expert evaluations. This combination of data creates a "ground truth" dataset, enabling the DeepView® System to distinguish between wounds likely to heal and those requiring intervention.
"By completing the truthing process for burn centers, this adds to Spectral AI’s largest comprehensive tissue dataset, encompassing over 3,000 biopsied images," said Dr. J. Michael DiMaio, Chairman of Spectral AI's Board of Directors. "This achievement reflects collaboration between internationally recognized burn experts, skilled dermatopathologists, and our dedicated engineers and data scientists. This multidisciplinary effort ensures that our technology evolves with precision and reliability, surpassing the limitations of traditional diagnostic methods."
The Company's Burn Biopsy Algorithm (BBA), developed alongside leading experts, integrates advanced machine learning with clinical insights, allowing the DeepView® System to identify healing trajectories with unprecedented effectiveness. By leveraging data from the largest burn tissue bank ever assembled, the DeepView® System is designed to provide clinicians with actionable information and reducing guesswork.
Now, Spectral AI is expanding its focus to emergency departments, where the stakes are equally high. The truthing process will include data collected during the critical early stages of care, enabling the DeepView® System to adapt to a broader range of clinical scenarios.
“Our team is committed to ensuring the DeepView® System delivers unparalleled diagnostic accuracy,” said Dr. DiMaio. “By incorporating data from diverse care settings, we aim to create a solution that seamlessly integrates into workflows across the spectrum of acute care."
Spectral AI has successfully enrolled and completed image collection for the BARDA burn study, a critical step in training the AI algorithm for the DeepView AI®-Burn device. The Company anticipates data results in late December to support an FDA De Novo submission in the first half of 2025, which seeks to classify the DeepView AI®-Burn system as a Class II medical device. Designed for use in multiple medical settings, the DeepView AI®-Burn system provides fast and accurate burn-depth assessments, empowering clinicians to make informed, early treatment decisions and improving care for both adult and pediatric burn victims.
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 wound care management 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 toward 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
When will Spectral AI (MDAI) submit its DeepView AI-Burn system for FDA approval?
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