Welcome to our dedicated page for Spectral AI news (Ticker: MDAIW), a resource for investors and traders seeking the latest updates and insights on Spectral AI stock.
Spectral AI Inc (MDAIW) pioneers AI-driven medical diagnostics through its DeepView System, transforming wound care assessments with real-time imaging technology. This dedicated news hub provides investors and medical professionals with essential updates on the company's advancements in predictive healthcare solutions.
Access authoritative information on regulatory milestones, product developments, and strategic partnerships that shape Spectral AI's position in medical technology. Our curated collection includes press releases about FDA clearances, clinical trial results, and innovations in emergency care diagnostics.
Key updates cover Spectral AI's work with military medical units, enhancements to its proprietary algorithms, and expansions into new healthcare markets. The platform serves as your primary source for understanding how MDAIW's technology improves decision-making in critical care environments.
Bookmark this page for structured access to verified company announcements. Check regularly to stay informed about Spectral AI's contributions to AI-powered diagnostics and their impact on patient outcomes across care settings.
Spectral AI (Nasdaq: MDAI) announced the addition of two new clinical trial sites at the University of California San Diego and the University of Utah, expanding its 2024 U.S. Burn Pivotal Study sites to 14. This expansion aims to capture more burn patients from emergency departments, diversify the patient population, and advance towards completing the study by the end of the year. The study will validate the AI-driven algorithm of Spectral AI's DeepView™ System for burn indication, with an expected completion in Q4 2024. FDA approval of the DeepView™ System is anticipated in 2025.
Spectral AI has achieved full pediatric patient enrollment at burn centers for its 2024 pivotal U.S. burn study, aimed at validating its DeepView™ System's AI-driven algorithm for burn indications. This study, set to conclude in Q4 2024, is the final step before seeking FDA approval in 2025.
The company met enrollment goals in just six months, demonstrating strong support from investigators. Spectral AI continues to enroll pediatric and adult patients through emergency departments to further validate its DeepView™ algorithm.
The DeepView™ System, utilizing proprietary multispectral imaging and a vast, clinically validated database, aims to provide immediate, accurate assessments of pediatric burn wounds. This non-invasive, cart-based system can be used directly at the patient’s location, enhancing early treatment decisions and potentially improving patient outcomes.
Spectral AI (Nasdaq: MDAI), an AI-driven medical diagnostics company, announced its inclusion in the Russell Microcap Index as of June 28, 2024, with trading commencing on July 1, 2024. CEO Peter M. Carlson emphasized that this inclusion boosts the company's visibility among investors. The company is advancing the commercialization of its AI-driven DeepView System, aimed at providing immediate wound healing assessments for burns and diabetic foot ulcers (DFU). In June, 50% of clinical trial sites were enrolled to validate the burn algorithm of DeepView, with trial completion expected in Q4 2024 and FDA approval sought in 2025. The company received UKCA Authorization in February to start sales in the UK and anticipates its first commercial revenue in H2 2024. Research & Development revenue rose by 24.6% to $6.3 million in Q1 2024, and the company's cash position improved to $10.2 million. A multi-year contract worth up to $150 million was awarded by the US Government for DeepView's advanced development, adding to over $250 million in non-dilutive support from the government. The Russell Microcap Index, a widely used benchmark, includes $10.5 trillion in assets.
Spectral AI (Nasdaq: MDAI) announced it has surpassed 90% of its pediatric enrollment target in burn centers for its 2024 pivotal study to validate the AI-driven DeepView™ System. This study, set to be completed in Q4 2024, aims for FDA approval in 2025. The DeepView™ System uses proprietary multispectral imaging and a database of over 340 billion data points to accurately assess burn depth in children, who face unique challenges in burn treatment due to thinner skin and different systemic responses. Spectral AI's system aims to provide immediate, non-invasive assessments, reducing stress and uncertainty for pediatric burn patients and their families.
Spectral AI (Nasdaq: MDAI), a leading AI company in medical diagnostics for wound care, has announced its support for an inquiry into potential market manipulation of its common stock. The inquiry, spearheaded by board member and major shareholder Erich Spangenberg, focuses on the illegal practice of naked short selling, which has allegedly inflated the company's public float by over 40%. Spectral AI is collaborating with Nasdaq and state securities authorities in Florida, Louisiana, and Texas to address this issue, aiming to strengthen market transparency and protect investors.
Spectral AI (Nasdaq: MDAI) will participate in the Northland Capital Markets Virtual Growth Conference on June 25, 2024. CEO Peter M. Carlson and CFO Vincent S. Capone will engage in virtual one-on-one meetings with institutional investors.
The company's DeepView™ System, which leverages multispectral imaging and a database of over 340 billion clinically validated data points, aims to distinguish between healthy and damaged tissue for better wound care decisions.
In February 2024, Spectral AI received UKCA authorization for the DeepView™ System for burn indications and anticipates generating its first commercial revenue this year. The company plans to file additional regulatory submissions in the UK and US in 2024 and 2025, with expectations to expand its commercial revenue platforms over the next two years.
Spectral AI (Nasdaq: MDAI) announced reaching 50% patient enrollment in its U.S. pivotal burn study, with 90 out of a target 240 patients enrolled. The study aims to validate the algorithm of the DeepView™ System, which utilizes AI for rapid and accurate assessment of burn wounds. Expected to complete enrollment by 2025, this trial represents the final step before seeking FDA approval. The DeepView™ System's efficacy will be compared against current clinician assessments. The system's image processing algorithm, trained on over 340 billion data points, is designed to enhance burn care by providing objective assessments to improve patient outcomes and reduce healthcare costs.
Spectral AI (Nasdaq: MDAI), an AI-driven medical diagnostics firm, announced its scheduled inclusion in the Russell Microcap® Index following the 2024 Russell US Indexes reconstitution, effective June 28, 2024. The company's proprietary DeepView™ System, which assesses wound healing potential, received UKCA Authorization and is expected to generate its first commercial revenue later in 2024. Spectral AI was also awarded a $150 million contract from the US Government for the DeepView™ System's advanced development. For Q1 2024, the company reported a 24.6% increase in R&D revenue, totaling $6.3 million, and a cash position of $10.2 million.
Spectral AI (Nasdaq: MDAI), an AI company specializing in medical diagnostics for wound care, announced its participation in Benzinga’s “AI Unleashed: Exploring the Possibilities” virtual event on May 30, 2024. CEO Peter M. Carlson will represent the company in a fireside chat starting at 11:25 am ET. The event will be live-streamed and accessible through the company's investor portal. This event serves as a platform for Spectral AI to showcase its advancements and future prospects in AI-driven medical diagnostics.
Spectral AI announced that its officers and directors purchased approximately 113,000 shares of its common stock in open market transactions on May 10 and May 15, 2024. The company is progressing toward commercializing its AI-driven DeepView™ System, which assesses wound healing potential, with initial applications in burns and diabetic foot ulcers. After receiving UKCA Authorization in February, Spectral AI plans to generate its first commercial product revenue in the second half of 2024. The company continues to advance clinical studies in the US and UK and aims to file additional regulatory submissions in 2024 and 2025. A $150 million multi-year contract from the US Government was awarded in September 2023 for the DeepView™ System's development, contributing to a total of $250 million in non-dilutive support. For Q1 2024, Research & Development revenue rose by 24.6% to $6.3 million, improving the company's cash position to $10.2 million.
