Spectral AI Completes Three Device Installations in Australia
Spectral AI (NASDAQ: MDAI) has completed the installation of three DeepView System devices in Australia, marking a significant expansion of its AI-driven burn assessment technology. The installations were completed at Concord Repatriation General Hospital in Sydney, Royal Adelaide Hospital in Adelaide, and Fiona Stanley Hospital in Perth.
The DeepView System, which received FDA Breakthrough Device Designation in 2018, utilizes multispectral imaging and AI algorithms to provide immediate, objective assessments of burn wound healing potential. The system leverages a proprietary database of over 340 billion clinically validated data points and is designed as a non-invasive, cart-based solution for healthcare mobility.
The deployment was facilitated through the Australian Special Access Scheme (SAS) in partnership with PolyNovo These installations will support the company's commercial roll-out strategy and FDA submission through real-world device trials and clinician evaluations.
Spectral AI (NASDAQ: MDAI) ha completato l'installazione di tre dispositivi DeepView System in Australia, segnando un'importante espansione della sua tecnologia di valutazione delle ustioni basata sull'IA. Le installazioni sono state effettuate presso il Concord Repatriation General Hospital di Sydney, il Royal Adelaide Hospital di Adelaide e il Fiona Stanley Hospital di Perth.
Il DeepView System, che ha ricevuto la Designazione di Dispositivo Innovativo dalla FDA nel 2018, utilizza l'imaging multispettrale e algoritmi di IA per fornire valutazioni immediate e obiettive del potenziale di guarigione delle ustioni. Il sistema sfrutta un database proprietario di oltre 340 miliardi di punti dati clinicamente validati ed è progettato come una soluzione non invasiva, basata su carrello, per la mobilità sanitaria.
Il dispiegamento è stato facilitato attraverso il Piano Speciale di Accesso Australiano (SAS) in collaborazione con PolyNovo. Queste installazioni supporteranno la strategia di rollout commerciale dell'azienda e la presentazione alla FDA tramite prove di dispositivi nel mondo reale e valutazioni da parte dei clinici.
Spectral AI (NASDAQ: MDAI) ha completado la instalación de tres dispositivos del sistema DeepView en Australia, marcando una expansión significativa de su tecnología de evaluación de quemaduras impulsada por IA. Las instalaciones se llevaron a cabo en el Concord Repatriation General Hospital en Sídney, el Royal Adelaide Hospital en Adelaida y el Fiona Stanley Hospital en Perth.
El sistema DeepView, que recibió la designación de Dispositivo Innovador de la FDA en 2018, utiliza imágenes multispectrales y algoritmos de IA para proporcionar evaluaciones inmediatas y objetivas del potencial de curación de las heridas por quemaduras. El sistema aprovecha una base de datos propietaria de más de 340 mil millones de puntos de datos clínicamente validados y está diseñado como una solución no invasiva, basada en carro, para la movilidad en el cuidado de la salud.
El despliegue se facilitó a través del Esquema de Acceso Especial Australiano (SAS) en asociación con PolyNovo. Estas instalaciones apoyarán la estrategia de lanzamiento comercial de la empresa y la presentación a la FDA a través de ensayos de dispositivos en el mundo real y evaluaciones de clínicos.
스펙트럴 AI (NASDAQ: MDAI)는 호주에 세 대의 DeepView 시스템 장치를 설치 완료하여 AI 기반 화상 평가 기술의 중요한 확장을 알렸습니다. 설치는 시드니의 콘코드 재환원 종합병원, 애들레이드의 로열 애들레이드 병원, 퍼스의 피오나 스탠리 병원에서 이루어졌습니다.
2018년 FDA 혁신 장치 지정서를 받은 DeepView 시스템은 다중 스펙트럼 이미징과 AI 알고리즘을 활용하여 화상 상처 치유 가능성에 대한 즉각적이고 객관적인 평가를 제공합니다. 이 시스템은 3400억 개 이상의 임상 검증된 데이터 포인트로 구성된 독점 데이터베이스를 활용하며, 의료 이동성을 위한 비침습적 카트 기반 솔루션으로 설계되었습니다.
이 배치는 PolyNovo와 협력하여 호주 특별 접근 계획(SAS)을 통해 이루어졌습니다. 이러한 설치는 회사의 상업적 출시 전략과 FDA 제출을 지원하기 위해 실제 장치 시험 및 임상의 평가를 통해 이루어질 것입니다.
Spectral AI (NASDAQ: MDAI) a terminé l'installation de trois dispositifs du système DeepView en Australie, marquant une expansion significative de sa technologie d'évaluation des brûlures alimentée par l'IA. Les installations ont été réalisées au Concord Repatriation General Hospital à Sydney, au Royal Adelaide Hospital à Adélaïde et au Fiona Stanley Hospital à Perth.
Le système DeepView, qui a reçu la désignation de Dispositif Innovant de la FDA en 2018, utilise l'imagerie multispectrale et des algorithmes d'IA pour fournir des évaluations immédiates et objectives du potentiel de guérison des blessures par brûlure. Le système s'appuie sur une base de données propriétaire de plus de 340 milliards de points de données cliniquement validés et est conçu comme une solution non invasive, sur chariot, pour la mobilité dans le secteur de la santé.
Le déploiement a été facilité par le biais du Schéma d'Accès Spécial Australien (SAS) en partenariat avec PolyNovo. Ces installations soutiendront la stratégie de déploiement commercial de l'entreprise et la soumission à la FDA par le biais d'essais de dispositifs dans le monde réel et d'évaluations par des cliniciens.
Spectral AI (NASDAQ: MDAI) hat die Installation von drei DeepView-Systemgeräten in Australien abgeschlossen, was eine bedeutende Erweiterung seiner KI-gesteuerten Technologie zur Bewertung von Verbrennungen darstellt. Die Installationen wurden im Concord Repatriation General Hospital in Sydney, im Royal Adelaide Hospital in Adelaide und im Fiona Stanley Hospital in Perth durchgeführt.
Das DeepView-System, das 2018 die FDA-Zulassung als Durchbruchgerät erhielt, nutzt multispektrale Bildgebung und KI-Algorithmen, um sofortige, objektive Bewertungen des Heilungspotenzials von Brandwunden bereitzustellen. Das System nutzt eine proprietäre Datenbank mit über 340 Milliarden klinisch validierten Datenpunkten und ist als nicht-invasive, fahrbare Lösung für die Mobilität im Gesundheitswesen konzipiert.
Die Bereitstellung wurde über das australische Sonderzugangsprogramm (SAS) in Partnerschaft mit PolyNovo erleichtert. Diese Installationen unterstützen die kommerzielle Roll-out-Strategie des Unternehmens und die FDA-Einreichung durch reale Gerätetests und klinische Bewertungen.
- FDA Breakthrough Device Designation status
- Expansion into Australian market with 3 hospital installations
- Partnership with established medical device company PolyNovo
- Large proprietary database of 340B+ validated data points
- Still pending FDA submission
- to evaluation phase, no commercial revenue yet
Insights
Spectral AI's installation of three DeepView Systems in Australian hospitals represents a tangible step forward in their commercialization strategy. The company has leveraged Australia's Special Access Scheme to place these AI-driven burn assessment devices in major medical centers across the country, creating real-world testing opportunities before full commercial launch.
The DeepView System offers significant clinical value through its non-invasive, objective assessment of burn wounds using multispectral imaging technology backed by an impressive 340 billion data points. This deployment is strategically important as it:
- Establishes presence in a second continental market
- Gathers essential clinical feedback to refine product offering
- Creates reference sites for future commercial expansion
- Strengthens their partnership with PolyNovo, an established player in burn treatments
Most critically, this Australian deployment will generate data to support Spectral AI's upcoming FDA submission in the US market. While representing modest initial deployment (just three units), this allows the company to build clinical champions and refine implementation protocols in preparation for wider commercialization.
For a company with a
Spectral AI's Australian deployment represents a strategic market entry through regulatory arbitrage, using the Special Access Scheme to establish clinical presence while the company works toward FDA approval. For a
The partnership with PolyNovo is particularly notable as it provides Spectral AI with access to established distribution channels and clinical relationships in the burn care market. This collaboration model offers a capital-efficient approach to market entry, critical for a company at this stage of development.
From an investment perspective, this deployment has several strategic benefits:
- Generates essential real-world data outside controlled clinical trials
- Creates international reference sites that can accelerate adoption post-approval
- Strengthens regulatory submission package for FDA with real-world implementation data
- Establishes early relationships with key opinion leaders in burn treatment
The company's focus on burn wound assessment addresses a specialized but critical clinical need. The DeepView System's ability to provide objective healing potential assessment represents a potential shift from subjective clinical judgment to data-driven decision making in burn treatment.
While not an immediate revenue driver, these installations position Spectral AI for the important transition from development-stage to commercial-stage operations. For investors, this represents tangible execution against the company's commercialization roadmap in an international market ahead of potential US approval.
DALLAS, March 06, 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 AI algorithms to predict burn healing potential, today announced the completion of the installation of three of the DeepView System devices in Australia. The Company, in partnership with global medical device company and burn wound therapy leader PolyNovo Limited (“PolyNovo”). The Company was able to utilize the Australian Special Access Scheme (SAS) to deploy three DeepView Systems at the Concord Repatriation General Hospital in Sydney, the Royal Adelaide Hospital in Adelaide and the Fiona Stanley Hospital in Murdoch (Perth). The installation of these devices will support the Company’s eventual commercial roll-out based on clinician evaluations and experiences using the device.
Spectral AI’s DeepView System is a predictive device that offers clinicians an immediate and objective assessment of a burn wound’s healing potential prior to treatment or other medical intervention. The image processing algorithm employed by the DeepView System utilizes multispectral imaging that is trained and tested against a proprietary database of more than 340 billion clinically validated data points. The DeepView System is non-invasive and cart-based, allowing for exceptional mobility within the healthcare setting.
"I am eager to start using DeepView on our patients. The imaging advancements have a definite potential to enhance patient care and improve outcomes, this technology was what we have been waiting for for many years and I'm looking forward to seeing how they can make a meaningful difference in treating our burn patients," stated Professor Peter Maitz, Director of the Burn Unit at Concord Repatriation General Hospital.
“We are pleased with the expansion of the use of our DeepView System in Australia, the support from PolyNovo and look forward to the evaluations and response from treating physicians,” stated Dr. J. Michael DiMaio, MD, Chairman of the Board at Spectral AI. “These real-world device trials underscore the transformative impact of the DeepView® System and its attendant use of artificial intelligence in burn wound care, offering clinicians an immediate, data-driven assessment tool that can improve treatment decisions and patient outcomes. I am proud to note that we are now in the field in two continents, gaining real world experience and response to the DeepView System. All of this will support our near-term FDA submission.”
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 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 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.
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FAQ
What is the significance of Spectral AI's DeepView System installation in Australia for MDAI?
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