Spectral AI Completes Pediatric Enrollment in Emergency Departments for U.S. Burn Pivotal Study
Spectral AI (NASDAQ: MDAI) has completed pediatric enrollment at U.S. emergency departments for its U.S. Burn Pivotal Study, one of the largest domestic burn studies ever conducted. The study aims to validate the AI-driven algorithm used in the company's DeepView® System, which received FDA Breakthrough Device Designation in 2018.
The DeepView System combines multispectral imaging with an AI algorithm trained on over 340 billion clinically-validated data points to assess burn healing potential. The system provides immediate, binary predictions of wound healing to support clinical decision-making for treatment plans.
The company plans to submit a De Novo classification request to the FDA in the first half of 2025 based on the study's data.
Spectral AI (NASDAQ: MDAI) ha completato l'arruolamento pediatrico nei reparti di emergenza degli Stati Uniti per il suo Studio Pivotal sulle Ustioni, uno dei più grandi studi sulle ustioni mai condotti a livello nazionale. Lo studio mira a convalidare l'algoritmo basato sull'IA utilizzato nel DeepView® System, che ha ricevuto la Designazione di Dispositivo Innovativo da parte della FDA nel 2018.
Il DeepView System combina l'imaging multispettrale con un algoritmo di intelligenza artificiale addestrato su oltre 340 miliardi di punti dati clinicamente convalidati per valutare il potenziale di guarigione delle ustioni. Il sistema fornisce previsioni immediate e binarie sulla guarigione delle ferite per supportare il processo decisionale clinico nei piani di trattamento.
L'azienda prevede di presentare una richiesta di classificazione De Novo alla FDA nella prima metà del 2025, basata sui dati dello studio.
Spectral AI (NASDAQ: MDAI) ha completado la inscripción pediátrica en los departamentos de emergencia de EE. UU. para su Estudio Pivotal sobre Quemaduras, uno de los estudios sobre quemaduras más grandes jamás realizados en el país. El estudio tiene como objetivo validar el algoritmo impulsado por IA utilizado en el DeepView® System, que recibió la Designación de Dispositivo Innovador de la FDA en 2018.
El DeepView System combina la imagenología multispectral con un algoritmo de IA entrenado con más de 340 mil millones de puntos de datos clínicamente validados para evaluar el potencial de curación de las quemaduras. El sistema proporciona predicciones inmediatas, binarias sobre la curación de heridas para apoyar la toma de decisiones clínicas en los planes de tratamiento.
La empresa planea presentar una solicitud de clasificación De Novo a la FDA en la primera mitad de 2025 basada en los datos del estudio.
스펙트럴 AI (NASDAQ: MDAI)는 미국 응급실에서 소아 환자 등록을 완료했습니다. 이는 미국에서 실시된 가장 큰 화상 연구 중 하나인 화상 주요 연구의 일환입니다. 이 연구는 2018년에 FDA의 혁신적 의료기기 지정을 받은 DeepView® System에서 사용되는 AI 기반 알고리즘을 검증하는 것을 목표로 하고 있습니다.
DeepView System은 다스펙트럼 이미징과 3400억 개 이상의 임상 검증된 데이터 포인트로 훈련된 AI 알고리즘을 결합하여 화상 치유 잠재력을 평가합니다. 이 시스템은 치료 계획을 위한 임상 의사 결정을 지원하기 위해 상처 치유에 대한 즉각적이고 이진 예측을 제공합니다.
회사는 연구 데이터를 바탕으로 2025년 상반기 중 FDA에 De Novo 분류 요청을 제출할 계획입니다.
Spectral AI (NASDAQ: MDAI) a terminé l'inscription des patients pédiatriques dans les services d'urgence des États-Unis pour son étude pivot sur les brûlures, l'une des plus grandes études nationales jamais réalisées sur ce sujet. L'étude vise à valider l'algorithme basé sur l'IA utilisé dans le DeepView® System, qui a obtenu la désignation de Dispositif Innovant par la FDA en 2018.
Le système DeepView combine l'imagerie multispectrale avec un algorithme d'IA formé sur plus de 340 milliards de points de données cliniquement validés pour évaluer le potentiel de guérison des brûlures. Le système fournit des prédictions binaires immédiates concernant la guérison des plaies pour soutenir la prise de décision clinique relative aux plans de traitement.
L'entreprise prévoit de soumettre une demande de classification De Novo à la FDA durant la première moitié de 2025, sur la base des données de l'étude.
Spectral AI (NASDAQ: MDAI) hat die Rekrutierung von Kindern in US-Notaufnahmen für seine US-Studie zu Verbrennungen abgeschlossen, eine der größten nationalen Studien zu Verbrennungen, die je durchgeführt wurde. Die Studie zielt darauf ab, den KI-gestützten Algorithmus zu validieren, der im DeepView® System verwendet wird, das 2018 von der FDA die Breakthrough Device Designation erhielt.
Das DeepView System kombiniert multispektrale Bildgebung mit einem auf über 340 Milliarden klinisch validierten Datenpunkten trainierten KI-Algorithmus, um das Heilungspotenzial von Verbrennungen zu bewerten. Das System bietet sofortige, binäre Vorhersagen über die Wundheilung, um die klinische Entscheidungsfindung für Behandlungspläne zu unterstützen.
Das Unternehmen plant, im ersten Halbjahr 2025 einen De Novo-Klassifizierungsantrag bei der FDA einzureichen, basierend auf den Daten der Studie.
- FDA Breakthrough Device Designation received in 2018
- Large proprietary database of 340+ billion clinically-validated data points
- Completion of pediatric enrollment in major U.S. burn study
- De Novo FDA submission planned for H1 2025
- None.
Insights
The completion of pediatric enrollment in emergency departments marks a crucial milestone in Spectral AI's U.S. Burn Pivotal Study, particularly significant given the unique challenges in conducting pediatric trials. The pediatric burn market represents a sensitive and high-stakes segment, where accurate assessment is paramount for optimal treatment outcomes.
The DeepView® System's approach to burn assessment represents a potential paradigm shift in clinical decision-making. The system's binary prediction model, supported by 340 billion data points, could significantly reduce the subjectivity in burn assessment - a persistent challenge in current clinical practice. This is particularly valuable in emergency settings where rapid, accurate decisions are critical for patient outcomes.
The planned De Novo classification request in H1 2025 is strategically significant. This regulatory pathway, chosen for novel devices without predicates, suggests DeepView's unique position in the market. While this route typically involves more rigorous evaluation than 510(k) clearance, successful classification could establish Spectral AI as the benchmark for future AI-driven burn assessment technologies.
The technology's key differentiators include:
- Multi-spectral imaging capability that likely captures data beyond visible light spectrum
- AI algorithm trained on an exceptionally large dataset
- Immediate assessment capability important for time-sensitive treatment decisions
- Validation across diverse patient populations, including the challenging pediatric segment
A successful De Novo classification could position Spectral AI to capture a significant share of the burn care market, estimated to grow substantially due to increasing demand for advanced wound care solutions. The completion of this pivotal study phase suggests the company is maintaining its development timeline, critical for both market entry and potential partnerships.
DALLAS, Jan. 28, 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. FDA in 2018, that uses multi-spectral imaging and algorithms to predict burn healing potential, today announced the completion of its pediatric enrollment at U.S. emergency departments for its U.S. Burn Pivotal Study. One of the largest domestic burn studies ever conducted, the U.S. Burn Pivotal Study is designed to validate the AI-driven algorithm used by the Company’s DeepView™ System for burn indication.
Using data from these burn center patients, the Company will pursue a De Novo classification from the U.S. Food and Drug Administration (“FDA”) for use of the DeepView™ System and expects to submit the request in the first half of 2025.
Spectral AI's DeepView™ System for burn indication is a predictive medical device that assesses the healing potential of burns by combining multispectral imaging with an AI-driven algorithm trained and tested against a proprietary database of more than 340 billion clinically-validated data points. By distinguishing between healing and non-healing tissue, the DeepView™ System provides an immediate and binary prediction of wound healing at examination that can support clinical decision-making regarding next step treatment plans.
“I am proud of the continuing work by our investigators, their dedicated staff and most critically study enrollees,” stated Dr. J. Michael DiMaio, MD, Chairman of the Board at Spectral AI. “The results of this U.S. Burn Pivotal Study will be used by our data science team and our panel of burn experts to complete years of work and bring this crucial advancement in burn wound assessment to patients and providers in the U.S.”
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 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
When will Spectral AI (MDAI) submit its DeepView System for FDA De Novo classification?
How many data points has the DeepView System's AI algorithm been trained on?
What is the main function of Spectral AI's (MDAI) DeepView System?
When did Spectral AI's (MDAI) DeepView System receive FDA Breakthrough Device Designation?
