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On Fri, 7 Mar, 12:04 AM UTC
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[1]
Spectral AI Completes Three Device Installations in Australia
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.
[2]
Spectral AI Completes Three Device Installations in Australia - Spectral AI (NASDAQ:MDAIW), Spectral AI (NASDAQ:MDAI)
DALLAS, March 06, 2025 (GLOBE NEWSWIRE) -- Spectral AI 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. 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 MDAISpectral AI Inc$1.49-4.49%OverviewMDAIWSpectral AI Inc$0.4000-%Market News and Data brought to you by Benzinga APIs
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Spectral AI has installed three DeepView System devices in Australian hospitals, marking a significant step in the global deployment of its AI-powered burn wound assessment technology.
Spectral AI (NASDAQ: MDAI), a Dallas-based predictive AI company, has announced the successful installation of three DeepView® System devices in Australian hospitals. This marks a significant expansion of the company's AI-driven burn wound assessment technology beyond North America 12.
The DeepView® System, which received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2018, utilizes multi-spectral imaging and AI algorithms to predict burn healing potential. This non-invasive, cart-based device offers clinicians an immediate and objective assessment of a burn wound's healing potential prior to treatment 1.
Spectral AI partnered with PolyNovo Limited, a global medical device company specializing in burn wound therapy, to facilitate the Australian rollout. The company utilized the Australian Special Access Scheme (SAS) to deploy the DeepView Systems at three hospitals 1:
Professor Peter Maitz, Director of the Burn Unit at Concord Repatriation General Hospital, expressed enthusiasm about the technology's potential to enhance patient care and improve outcomes in burn treatment 12.
Dr. J. Michael DiMaio, Chairman of the Board at Spectral AI, highlighted the significance of these real-world device trials in demonstrating the transformative impact of AI in burn wound care. He noted that the company is now operating on two continents, gaining valuable real-world experience that will support their upcoming FDA submission 1.
Spectral AI focuses on developing medical diagnostics for faster and more accurate treatment decisions in wound care. Their initial applications involve patients with burns and diabetic foot ulcers. The company aims to revolutionize wound care management through its "Seeing the Unknown®" approach with the DeepView® System 12.
While specific financial details were not disclosed, the expansion into the Australian market represents a significant step in Spectral AI's global commercialization strategy. The company's stock (NASDAQ: MDAI) was reported at $1.49, showing a 4.49% decrease, indicating potential market reactions to this news 2.
As Spectral AI continues to gather real-world data and clinician feedback from these installations, it moves closer to its goal of transforming burn wound care on a global scale. The company's progress in Australia will likely inform its strategies for further international expansion and upcoming regulatory submissions.
Spectral AI, a medical technology company, adds three new clinical trial sites for its DeepView® system and increases its patent portfolio to 26 granted patents, bolstering its position in AI-driven medical imaging.
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Spectral AI, a medical technology company, expands its burn study with new clinical trial sites and achieves significant patient enrollment milestones in its U.S. Burn Pivotal Study.
2 Sources
2 Sources
Spectral AI completes proof-of-concept for a module in its DeepView® System, offering precise burn wound measurement and healing potential assessment using AI technology.
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Spectral AI, developer of the AI-driven DeepView® System for burn healing prediction, schedules its Q4 and full year 2024 financial results conference call for March 27, 2025.
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Spectral AI, an AI company focused on medical diagnostics in wound care, has scheduled its 2024 third quarter financial results and conference call for November 6, 2024.
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