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CORRECTION: Spectral AI Schedules 2024 Fourth Quarter and Full Year Financial Results and Conference Call
GlobeNewswire· 2025-02-28 15:34
Core Viewpoint - Spectral AI, Inc. will report its financial results for the fourth quarter and full year ended December 31, 2024, on March 27, 2025, after market close, and will host a conference call to discuss these results [1]. Company Overview - Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics, particularly in wound care, with initial applications for burn patients [3]. - The company has developed the AI-driven DeepView® System, which utilizes multi-spectral imaging and AI algorithms to predict burn healing potential and has received Breakthrough Device Designation from the FDA in 2018 [1][3]. - DeepView aims to provide clinicians with an objective and immediate assessment of a wound's healing potential, thereby improving patient outcomes and reducing healthcare costs [3]. Financial Reporting - The financial results for the fourth quarter and full year will be reported on March 27, 2025, with a corresponding conference call scheduled for 5:00 pm Eastern Time [1][2].
Spectral AI Schedules 2024 Fourth Quarter and Full Year Financial Results and Conference Call
GlobeNewswire· 2025-02-28 13:00
Core Insights - Spectral AI is set to report its financial results for Q4 and the full year ended December 31, 2024, on March 27, 2025, after market close [1] - The company will host a conference call at 5:00 pm Eastern Time to discuss these results [1] Company Overview - Spectral AI, based in Dallas, focuses on predictive AI for medical diagnostics, particularly in wound care, with initial applications for burn patients [2] - The company's DeepView System utilizes multi-spectral imaging and AI algorithms to assess burn healing potential, aiming to improve treatment decisions and patient outcomes [2] - DeepView is designed to provide objective and immediate assessments of wound healing potential, with the goal of exceeding current standards of care and reducing healthcare costs [2]
Spectral AI Strengthens Financial Position Ahead of FDA Submission
GlobeNewswire· 2025-02-18 12:00
Core Insights - Spectral AI has satisfied its final obligations under its debt facility with Yorkville Advisors and retains access to an additional financing of up to $17.5 million under an existing standby equity purchase agreement [1] Company Overview - Spectral AI, based in Dallas, focuses on predictive AI for medical diagnostics, particularly in wound care, with initial applications for burn patients and diabetic foot ulcers [3] - The company's DeepView System utilizes multi-spectral imaging and AI algorithms to predict burn healing potential, aiming to provide faster and more accurate treatment insights, thereby improving patient outcomes and reducing healthcare costs [3] Future Developments - The company is advancing towards its FDA submission to bring its technology to burn care institutions across the U.S. [2]
FDA Approval Race: AI-Powered Innovations Reshape the Healthcare Landscape
Prnewswire· 2025-02-11 14:00
Core Insights - The article discusses the transformative impact of Artificial Intelligence (AI) in the healthcare sector, particularly through the lens of Project Stargate, which has a monumental budget of $500 billion aimed at revolutionizing healthcare [1] - A recent Deloitte poll indicates that 40% of health executives believe generative AI (genAI) is beneficial for their businesses, highlighting a growing acceptance of AI technologies in healthcare [1] - The Generative AI in Healthcare Market is projected to grow from $1.7 billion in 2023 to $19.99 billion by 2032, reflecting a robust compound annual growth rate (CAGR) of 31.5% [2] Company Developments - Avant Technologies, Inc. has partnered with Ainnova Tech to advance Ainnova's Vision AI platform, which focuses on early disease detection using AI [3] - Fortrea has been selected as the contract research organization (CRO) to assist Ainnova in its upcoming clinical studies aimed at obtaining FDA approval for the Vision AI platform [4] - The partnership between Avant and Ainnova is crucial for marketing Ainnova's technology portfolio in the U.S., Canada, and Europe, with the success of clinical studies being vital [5] Clinical Trials and FDA Interaction - Ainnova plans to request a pre-submission meeting with the FDA to discuss clinical testing requirements for its Vision AI platform, with expectations to submit the application in the coming weeks [6] - Ainnova is also working on obtaining clearance for four algorithms related to early detection of various health conditions, including cardiovascular risk and chronic kidney disease [7] Collaborations and Initiatives - Avant Technologies has formed a collaboration with Roche to launch a pilot program in Costa Rica aimed at combating diabetic retinopathy using VisionAI for automated retinal image analysis [8] - Roche emphasizes the importance of timely disease diagnosis to improve clinical outcomes and aims to replicate this model for other diseases [9] Market Trends and Innovations - The AI Revolutionizing Industries Market is projected to grow at a CAGR of 39.7%, reaching $1.1 trillion by 2029, indicating a significant trend towards AI integration across various sectors [2] - Spectral AI, Inc. has completed data analytics for its U.S. Burn Pivotal Study, which aims to validate its AI-driven DeepView® System for assessing burn wound healing potential [10][11] - Tempus AI, Inc. has launched an AI-enabled personal health concierge app named olivia, designed to centralize patient health data and provide actionable insights [12][13] - Absci Corporation is collaborating with Owkin to develop novel therapies by combining AI-driven target selection with generative antibody design [14] - GE Healthcare has received FDA clearance for its updated Voluson™ Expert Series ultrasound systems, which integrate AI-powered features to enhance imaging performance in women's healthcare [16][17]
Spectral AI Completes Data Analysis for U.S. Burn Pivotal Study
GlobeNewswire· 2025-02-07 13:21
Core Insights - Spectral AI has completed data analytics for its U.S. Burn Pivotal Study, one of the largest domestic burn studies, aimed at validating the AI-driven algorithm of its DeepView System for burn indications [1][2] - The DeepView System utilizes multi-spectral imaging and AI algorithms to predict burn healing potential, providing immediate assessments that can enhance clinical decision-making [1][3] - The results from the study show strong sensitivity and specificity metrics when compared to traditional assessments by burn and emergency room physicians [2] Company Overview - Spectral AI, based in Dallas, focuses on predictive AI for medical diagnostics, particularly in wound care, with initial applications for burns and diabetic foot ulcers [3] - The DeepView System aims to revolutionize wound care management by providing objective and immediate assessments of burn wounds, potentially improving patient outcomes and reducing healthcare costs [3] Future Plans - The company plans to pursue a De Novo classification request from the FDA for the DeepView System in burn care, with an expected submission by June 2025 [5]
Spectral AI Completes Pediatric Enrollment in Emergency Departments for U.S. Burn Pivotal Study
GlobeNewswire· 2025-01-28 14:44
Core Insights - Spectral AI has completed pediatric enrollment for its U.S. Burn Pivotal Study, one of the largest domestic burn studies aimed at validating the AI-driven algorithm of its DeepView® System for burn indication [1][4] - The company plans to pursue a De Novo classification from the U.S. FDA for the DeepView™ System, with a submission expected in the first half of 2025 [2] - The DeepView™ System utilizes multispectral imaging and an AI-driven algorithm trained on over 340 billion clinically-validated data points to assess burn healing potential, providing immediate predictions to support clinical decision-making [3] Company Overview - Spectral AI, based in Dallas, focuses on predictive AI for medical diagnostics, particularly in wound care, with initial applications for burns and diabetic foot ulcers [4] - The DeepView® System aims to revolutionize wound care management by offering objective assessments of healing potential, which could lead to improved patient outcomes and reduced healthcare costs [4]
Spectral AI Provides Update to Investors
GlobeNewswire· 2025-01-22 13:00
Core Insights - Spectral AI anticipates reporting annual revenue exceeding $28 million, marking the highest revenue in the company's history, driven by a focus on its BARDA contract and improved gross profit margins for 2024 [2] Company Overview - Spectral AI, based in Dallas, specializes in predictive AI for medical diagnostics, particularly in wound care, with applications for burn and diabetic foot ulcer patients [3] - The company's DeepView System utilizes multi-spectral imaging and algorithms to assess wound healing potential, aiming to enhance treatment decisions and patient outcomes while reducing healthcare costs [3] Financial Expectations - The company expects to report over $5 million in cash alongside its revenue results [2] - Complete financial results for the year ended December 31, 2024, are anticipated to be reported in March 2025 [4]
Spectral AI Announces Confirmation of Compliance of its Nasdaq Listing Requirements
GlobeNewswire· 2024-12-23 13:00
Company Overview - Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics, particularly in wound care, with initial applications for burns and diabetic foot ulcers [1] - The company aims to revolutionize wound care management through its DeepView System, which provides objective assessments of wound healing potential [1] Product Details - The DeepView System utilizes multi-spectral imaging and algorithms to predict burn healing potential and has received Breakthrough Device Designation from the U.S. FDA in 2018 [5] - The system is designed to offer faster and more accurate treatment insights, improving patient outcomes and reducing healthcare costs [1] Compliance and Regulatory Progress - On December 20, 2024, the company received a letter from Nasdaq confirming compliance with all applicable listing standards, eliminating the need for a further hearing regarding compliance [5] - The company is also making progress towards its submission to the FDA, reflecting its commitment to innovation and excellence in serving stakeholders [3]
Spectral AI Comments on Compliance with Nasdaq Listing Rule 5550(b)(2)
GlobeNewswire· 2024-12-13 16:53
Core Viewpoint - Spectral AI has regained compliance with Nasdaq Listing Rule 5550(b)(2), maintaining a market value of over $35 million for the last 10 consecutive business days [1][2]. Company Overview - Spectral AI, based in Dallas, focuses on predictive AI for medical diagnostics, particularly in wound care, with applications for burn and diabetic foot ulcer patients [3]. - The company's DeepView System utilizes multi-spectral imaging and algorithms to assess wound healing potential, aiming to improve treatment decisions and patient outcomes while reducing healthcare costs [3]. Compliance Details - The company has notified Nasdaq of its compliance status and is awaiting confirmation from the exchange regarding its market value [2].
Spectral AI Completes Truthing of Burn Center Images, Initiates Emergency Department Image Review
GlobeNewswire News Room· 2024-12-02 13:39
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 acc ...