Welcome to our dedicated page for Spectral AI news (Ticker: MDAI), a resource for investors and traders seeking the latest updates and insights on Spectral AI stock.
Spectral AI, Inc. (Nasdaq: MDAI) is a predictive AI company in the healthcare sector developing the DeepView® System for medical diagnostics in wound care, with a primary focus on burns. The news flow around Spectral AI centers on the progress of its DeepView technology, regulatory milestones, clinical evidence, and financing activities that support ongoing development.
Company news frequently includes updates on regulatory submissions and interactions, such as the announced submission of a De Novo 510(k) marketing clearance application to the U.S. Food and Drug Administration for the DeepView System intended for burn care settings. Spectral AI also issues quarterly financial results that discuss research and development revenue, gross margin trends, operating expenses, and the impact of its BARDA Project BioShield contract on reported figures.
Another recurring theme in MDAI news is the company’s participation in professional burn conferences and scientific meetings. Releases describe multiple presentations and posters featuring the DeepView System at events such as the British Burn Association conference, the European Burns Association Congress, and U.S. regional burn conferences. These items highlight clinical studies, reader studies, and early experiences with DeepView in burn centers in the United Kingdom, the United States, and other regions.
Investors and healthcare professionals following MDAI news can also expect announcements on capital raises, including securities purchase agreements, private placements of warrants and pre-funded warrants, and debt facilities that provide growth capital for further development and potential commercialization. Scheduling notices for earnings calls and webcasts appear alongside these updates, offering additional context on the company’s strategy and operational progress.
For users tracking MDAI, this news page provides a focused view of Spectral AI’s ongoing work to advance AI-driven burn wound diagnostics, its financial position, and its engagement with the global burn care community.
Spectral AI (NASDAQ: MDAI) has submitted a De Novo 510k marketing clearance application to the FDA for its DeepView® System, a breakthrough medical device designed for burn care settings. The DeepView System, which received FDA Breakthrough Device Designation in 2018, combines multi-spectral imaging with AI algorithms to predict burn wound healing potential.
The system provides non-invasive healing predictions on the day of injury and up to 7 days post-injury, enabling clinicians to make earlier and more informed treatment decisions. The De Novo regulatory pathway was chosen due to the technology's novel nature, as no predicate device exists in the U.S. market.
The development has been supported by federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, and BARDA through multiple contract awards since 2013, with the current contract number being 75A50123C00049.
Spectral AI's (NASDAQ: MDAI) DeepView® System has achieved a remarkable 95.3% accuracy in burn healing assessment, as published in the prestigious Burns journal. The multi-center clinical study validates the system's effectiveness in using AI-driven multi-spectral imaging to predict burn healing potential across diverse clinical settings.
The technology enables clinicians to make earlier, more informed decisions about healing time and surgical requirements, potentially improving patient outcomes. This publication in Burns, a leading peer-reviewed medical journal of the International Society for Burn Injuries, represents the first multi-center evaluation of AI-enhanced multispectral imaging in burn assessment.
Spectral AI (NASDAQ: MDAI), a company specializing in AI-driven DeepView® System for burn healing prediction through multi-spectral imaging and AI algorithms, has announced its Q1 2025 earnings release schedule. The company will report its financial results for the quarter ending March 31, 2025, on Tuesday, May 13, 2025, after market close.
A conference call to discuss the results will be held at 5:00 pm Eastern Time. Investors can participate by dialing 833-630-1956 (U.S.) or 412-317-1837 (International). A simultaneous webcast will be available through the Events & Presentations section of Spectral AI's Investor Relations website.
Spectral AI (NASDAQ: MDAI) showcased its DeepView® System at the American Burn Association annual meeting in Phoenix, Arizona. The event, attended by over 2,200 burn care professionals, highlighted significant achievements in burn wound assessment technology.
Key findings presented by Leslie Tan of Newcastle Burns Centre revealed the DeepView System's impressive 95% accuracy rate in predicting burn wound healing potential within 21 days. The technology received additional recognition when Zeeshan Sheikh of Wythenshawe Hospital won Best in Category for his presentation on patient experience with AI-Enhanced Multispectral Imaging.
The DeepView System, which combines multi-spectral imaging with AI algorithms, is currently operational in several NHS hospitals in the United Kingdom. Newcastle Burn Centre, treating approximately 500 burn patients annually, became the first institution globally to conduct an independent evaluation of this technology.
Spectral AI (NASDAQ: MDAI) reported its Q4 and full-year 2024 financial results, highlighting significant achievements in its AI-driven wound care diagnostics business. The company's research and development revenue reached $30 million in 2024, marking a 63.5% increase from 2023, primarily driven by their BARDA PBS contract.
Key financial metrics include Q4 2024 R&D revenue of $7.6 million and a gross margin of 44.0%. The company reported a full-year net loss of $15.3 million. As of December 31, 2024, cash stood at $5.2 million, with additional Q1 2025 financing of $11.2 million through debt and equity.
Notable achievements include successful results from the US Burn Validation Study, where their DeepView System demonstrated 86.6% sensitivity in identifying non-healing tissue, significantly outperforming burn physicians' 40.8%. The company plans FDA submission in Q2 2025 and anticipates first commercial revenue in H2 2025.