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Spectral AI Inc is an AI company, focused on predictive medical diagnostics. Spectral is devoting substantially all of its efforts towards the research and development of its DeepView System, an internally developed MSI device that has designated FDA BDD status. Its DeepView System uses proprietary algorithms to distinguish between damaged and healthy human tissue invisible to the naked eye, providing Day One healing assessments in seconds. The Company's output is specifically engineered to allow the physician to make a more accurate, timely, and informed decision regarding the treatment of the patient's wound.
Latest News: DALLAS, April 30, 2024 (GLOBE NEWSWIRE) -- Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence (AI) company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, today announced that the company received the Commitment to Quality Achievement Award from the Texas Manufacturer Assistance Center (TMAC) for their UKCA Mark Attainment. “Spectral AI is honored to be recognized as an upcoming leader in the Texas Manufacturing space,” said Louis Percoco, Spectral AI’s General Manager. “Our mission is to bring innovation and solutions to wound care through the company’s DeepView™ technology with the utmost quality and a strong manufacturing backbone is vital as we continue driving towards commercialization of the product. We are proud to be part of the local business infrastructure and appreciate the support and recognition for the focus the team brought to the table by the Texas manufacturing community.” TMAC, which is associated with the Manufacturing Extension Partnership (MEP) of the National Institute of Standards and Technology (NIST) aims for Texas manufacturers to achieve profitable growth and increased competitiveness. The non-profit program supports Texas manufacturers by granting business management consulting services, new technologies implementation, operations streamlining, workforce development, and strategic planning. Their services extend beyond manufacturers and also include distribution, logistics, construction, healthcare, and government entities. This award heralds in a new era of quality excellence and leadership for Spectral AI as they move toward product commercialization.
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.
Spectral AI (Nasdaq: MDAI) announced the results of its 2024 Annual Meeting of Stockholders held on May 14, 2024. Key outcomes include the election of six directors to serve until the next Annual Meeting, and the approval of four proposals. Newly elected directors are Richard Cotton, Peter M. Carlson, Dr. J. Michael DiMaio, Martin Mellish, Deepak Sadagopan, and Marion Snyder. Additionally, stockholders ratified the adoption of the 2023 Long Term Incentive Plan, the appointment of KPMG LLP as the company's independent auditor for the 2024 fiscal year, and the reservation and issuance of shares of common stock pursuant to the Standby Equity Purchase Agreement. The Board also expanded to seven members and appointed Erich Spangenberg as a new director, who had previously declined to stand for reelection but accepted the Board’s request to serve.
Spectral AI, Inc. (Nasdaq: MDAI) announced their Q1 2024 financial results, showcasing a $6.3 million Research & Development revenue, cash reserves of $10.2 million, and the deployment of DeepView AI®-Burn devices in the UK with expected commercial revenue in 2H 2024. The company plans further regulatory submissions in the US and UK for the DeepView™ System in 2024 and 2025.
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