Spectral AI Outlines U.S. Regulatory Pathway for DeepView® System for Burn Indication
Spectral AI (Nasdaq: MDAI) has outlined its regulatory strategy to enter the U.S. market with DeepView AI®-Burn, a predictive medical device for burn assessment. The company plans to pursue a De Novo submission to the FDA, requesting classification as a Class II medical device. This decision is based on the unique characteristics of DeepView AI®-Burn, which received Breakthrough Device Designation in 2018.
The device combines multi-spectral imaging with AI to assess burn healing potential, trained on over 340 billion clinically validated data points. Spectral AI expects to submit the De Novo request in Q2 2025. The company recently completed patient enrollment for its U.S. Burn Pivotal Study, marking a significant milestone in its development process.
Spectral AI (Nasdaq: MDAI) ha delineato la sua strategia normativa per entrare nel mercato statunitense con DeepView AI®-Burn, un dispositivo medico predittivo per la valutazione delle ustioni. L'azienda prevede di presentare un De Novo submission alla FDA, richiedendo la classificazione come dispositivo medico di Classe II. Questa decisione è basata sulle caratteristiche uniche di DeepView AI®-Burn, che ha ricevuto la Breakthrough Device Designation nel 2018.
Il dispositivo combina imaging multispettrale con IA per valutare il potenziale di guarigione delle ustioni, addestrato su oltre 340 miliardi di punti dati clinicamente validati. Spectral AI si aspetta di presentare la richiesta De Novo nel Q2 2025. L'azienda ha recentemente completato l'arruolamento dei pazienti per il suo Studio Pivotal sulle Ustioni negli Stati Uniti, segnando un traguardo significativo nel suo processo di sviluppo.
Spectral AI (Nasdaq: MDAI) ha delineado su estrategia regulatoria para entrar en el mercado estadounidense con DeepView AI®-Burn, un dispositivo médico predictivo para la evaluación de quemaduras. La compañía planea presentar una De Novo submission a la FDA, solicitando la clasificación como dispositivo médico de Clase II. Esta decisión se basa en las características únicas de DeepView AI®-Burn, que recibió la Breakthrough Device Designation en 2018.
El dispositivo combina imágenes multispectrales con IA para evaluar el potencial de curación de las quemaduras, entrenado con más de 340 mil millones de puntos de datos clínicamente validados. Spectral AI espera presentar la solicitud De Novo en Q2 2025. La empresa ha completado recientemente la inscripción de pacientes para su Estudio Pivotal de Quemaduras en EE. UU., marcando un hito significativo en su proceso de desarrollo.
스펙트럴 AI(Nasdaq: MDAI)는 DeepView AI®-Burn이라는 화상 평가를 위한 예측 의료 장치를 미국 시장에 진입하기 위한 규제 전략을 설명했습니다. 이 회사는 FDA에 De Novo 제출을 진행할 계획이며, 이 장치를 클래스 II 의료 기기로 분류해 줄 것을 요청하고 있습니다. 이 결정은 2018년에 Breakthrough Device Designation을 받은 DeepView AI®-Burn의 독특한 특성에 기반합니다.
이 장치는 멀티스펙트럴 이미징과 AI를 결합하여 화상 치유 잠재력을 평가하며, 3400억 개 이상의 임상적으로 검증된 데이터 포인트를 기반으로 훈련되었습니다. 스펙트럴 AI는 2025년 2분기에 De Novo 요청서를 제출할 것으로 예상하고 있으며, 최근 미국 화상 주요 연구의 환자 등록을 완료하여 개발 과정에서 중요한 이정표를 기록했습니다.
Spectral AI (Nasdaq: MDAI) a décrit sa stratégie réglementaire pour entrer sur le marché américain avec DeepView AI®-Burn, un dispositif médical prédictif pour l'évaluation des brûlures. L'entreprise prévoit de soumettre une De Novo submission à la FDA, en demandant la classification en tant que dispositif médical de Classe II. Cette décision repose sur les caractéristiques uniques de DeepView AI®-Burn, qui a reçu la Breakthrough Device Designation en 2018.
Le dispositif combine imagerie multispectrale avec IA pour évaluer le potentiel de guérison des brûlures, ayant été formé sur plus de 340 milliards de points de données cliniquement validés. Spectral AI s'attend à soumettre la demande De Novo au Q2 2025. L'entreprise a récemment terminé le recrutement de patients pour son étude pivot sur les brûlures aux États-Unis, marquant une étape significative dans son processus de développement.
Spectral AI (Nasdaq: MDAI) hat seine regulatorische Strategie skizziert, um mit DeepView AI®-Burn, einem prädiktiven medizinischen Gerät zur Bewertung von Verbrennungen, in den US-Markt einzutreten. Das Unternehmen plant, einen De Novo-Antrag bei der FDA einzureichen und die Klassifizierung als Medizinprodukt der Klasse II zu beantragen. Diese Entscheidung beruht auf den einzigartigen Eigenschaften von DeepView AI®-Burn, das 2018 den Breakthrough Device Designation erhalten hat.
Das Gerät kombiniert multispektrale Bildgebung mit KI, um das Heilungspotenzial von Verbrennungen zu bewerten und wurde mit über 340 Milliarden klinisch validierten Datenpunkten trainiert. Spectral AI erwartet, den De Novo-Antrag im Q2 2025 einzureichen. Das Unternehmen hat kürzlich die Patienten-Einschreibung für seine US-Verbrennungsstudie abgeschlossen, was einen bedeutenden Meilenstein in seinem Entwicklungsprozess darstellt.
- DeepView AI®-Burn received FDA Breakthrough Device Designation in 2018
- Completed adult and pediatric patient enrollment for U.S. Burn Pivotal Study
- Plans to submit De Novo request to FDA in Q2 2025
- DeepView® System trained on over 340 billion clinically validated data points
- Potential to change the standard of care in burn assessment and treatment
- Long regulatory process may delay market entry
- No guarantee of FDA approval for De Novo submission
- Potential competition from future alternative technologies
Spectral AI's DeepView® System for burn indication represents a significant advancement in burn assessment technology. The system's AI-driven algorithm, trained on 340 billion data points, offers a binary prediction of wound healing potential. This could revolutionize burn treatment by enabling more informed and timely decisions.
The pursuit of a De Novo submission for FDA clearance is strategic, given the device's unique characteristics. If successful, this would establish a new product category, potentially positioning Spectral AI as a market leader. The Breakthrough Device Designation already obtained highlights the system's potential to significantly improve upon current diagnostic methods.
However, investors should note that the FDA submission is planned for Q2 2025, indicating a considerable waiting period before potential market entry. The success of this novel approach in the regulatory process will be important for the company's future prospects.
The regulatory strategy outlined by Spectral AI for DeepView AI®-Burn is well-aligned with current FDA pathways for innovative medical devices. The choice of a De Novo submission is appropriate given the lack of predicate devices and could set a new standard for burn assessment tools.
The Breakthrough Device Designation obtained in 2018 may expedite the review process, potentially reducing time-to-market. However, investors should be aware that even with this designation, the regulatory process remains rigorous and outcomes are not guaranteed.
If successful, this approach could pave the way for faster approvals of additional applications of the DeepView® System, creating a platform technology with multiple revenue streams. This strategy demonstrates Spectral AI's long-term vision for market penetration and expansion in the medical device sector.
From a financial perspective, Spectral AI's regulatory strategy for DeepView AI®-Burn presents both opportunities and challenges. The potential creation of a new product category through the De Novo process could give the company a first-mover advantage in a niche market, potentially leading to strong initial market share and pricing power.
However, investors should consider the extended timeline to potential commercialization, with FDA submission not expected until Q2 2025. This implies continued R&D expenses and no immediate revenue from this product line, which may impact short-term financial performance.
The platform nature of the DeepView® System suggests potential for multiple revenue streams if additional applications are developed and approved. This could provide long-term growth opportunities but will require continued investment. Overall, while promising, the company's near-term financial outlook remains speculative pending regulatory outcomes.
DALLAS, Sept. 17, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today provided an outline of its regulatory pathway strategy to enter the U.S. market with its flagship DeepView® System for burn indication (“DeepView AI®-Burn”).
DeepView AI®-Burn, which received Breakthrough Device Designation from the U.S. Food and Drug Administration (“FDA”) in 2018, is a predictive medical device that assesses the healing potential of burns by combining multi-spectral 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 that can support clinical decision-making regarding next step treatment plans.
“We have entered an exciting phase at Spectral AI with the recently announced completion of adult and pediatric patient enrollment at U.S. burn centers for our U.S. Burn Pivotal Study,” said Trudy Estridge, Sr. Director of Regulatory Affairs at Spectral AI. “The unique characteristics of DeepView AI®-Burn meet criteria that, to our knowledge, no approved or cleared alternatives registered by the FDA currently possess. Therefore, the Company has decided to pursue a De Novo submission requesting classification of DeepView AI®-Burn as a Class II medical device. This process provides a pathway for FDA clearance for low- or medium-risk medical devices with no existing predicate, or no substantial equivalence. We expect to submit this request in the second quarter of 2025 and, if granted, the FDA will create a new product code for the DeepView® System.”
DeepView AI®-Burn was previously granted Breakthrough Device Designation by meeting two key criteria determined by the FDA. First, the Device provides for a more effective treatment or diagnosis relative to the current standard of care in the U.S. Second, the Device represents a novel technology that has the potential to lead to a clinical improvement in the diagnosis, treatment, cure, mitigation, or prevention of the life-threatening or irreversibly debilitating disease or condition.
“The process of developing an innovative healthcare solution with the potential to change the standard of care is a long and challenging process,” said Peter M. Carlson, Chief Executive Officer of Spectral AI. “Our progress to date reflects the commitment of our dedicated team of employees and consultants, government partners, and study participants. I remain exceedingly grateful for their continuing support. As we pursue FDA submission for DeepView AI®-Burn, we are following a process that we believe can capitalize on the platform nature of our DeepView® System and expedite the commercialization of additional pipeline applications. We look forward to our future with confidence.”
The DeepView® System wound healing assessment platform empowers clinicians at all levels with the insights necessary for timely and informed treatment decisions. The use of the DeepView® System aims to deliver expedited treatment, reduce potential complications, improve patient outcomes, and more efficiently allocate limited healthcare resources.
For more information on the FDA De Novo process and Breakthrough Device program, visit:
BreakthroughDevicesProgram@fda.hhs.gov
https://www.nature.com/articles/s41746-024-01021-y
https://medicaldeviceacademy.com/de-novo-review-timeline/
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm
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. The DeepView® System 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 to change the current standard of care, the DeepView® System 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 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.
Investors:
The Equity Group
Devin Sullivan
Managing Director
dsullivan@equityny.com
Conor Rodriguez
Analyst
crodriguez@equityny.com
FAQ
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