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 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) has announced a 30% increase in its patent portfolio, strengthening its proprietary AI-driven DeepView System for wound assessment. The company now holds 26 granted patents (12 U.S. and 14 international) and 38 pending applications worldwide. These patents cover various aspects of the DeepView System, including tissue classification, machine learning, and high-precision imaging.
CEO Peter M. Carlson emphasized the novel nature of the DeepView System and its ability to provide immediate, objective wound healing assessments. The company plans to commence product commercialization initiatives in late 2024 through 2026. Board member Erich Spangenberg, a recognized IP expert and the company's largest shareholder, is actively supporting management in building a strong intellectual property position.
Spectral AI (Nasdaq: MDAI) has added three new U.S. Clinical Trial Sites for its 2024 Burn Pivotal Study, bringing the total to 16 sites including burn centers and Emergency Departments. The new sites are:
- University Medical Center Burn Center at Texas Tech University Health Sciences Center
- Tampa General Hospital Burn Center
- University of South Alabama Health Emergency Department
The study aims to validate the AI-driven algorithm used by Spectral AI's DeepView™ System for burn indication. It's expected to be the final clinical trial before seeking FDA approval in 2025. The DeepView™ System uses multispectral imaging and a database of over 340 billion clinically validated data points to provide rapid, objective burn wound assessments.
Spectral AI (Nasdaq: MDAI), an AI company focused on medical diagnostics for wound care, has provided an update on its efforts to expose potential market manipulation of its common stock, primarily through naked short selling. The company's largest shareholder, Erich Spangenberg, sent letters to Nasdaq and state securities authorities in Florida, Louisiana, and Texas on June 24, 2024, highlighting potential violations of Nasdaq rules and federal and state laws. A follow-up letter dated July 15, 2024, urges authorities to investigate the likely prevalence of naked short selling affecting MDAI shares and other de-SPAC transaction companies. The company has filed these letters via Form 8-K with the SEC, making them publicly available.
Spectral AI (Nasdaq: MDAI) has signed an MOU with PolyNovo to potentially deploy its DeepView System for burn indication in Australia. The agreement aims for deployment at Royal Adelaide Hospital and The Alfred Hospital in Melbourne under Australia's Special Access Scheme (SAS). Spectral AI’s DeepView System provides clinicians with immediate, objective assessments of burn wounds using a predictive device based on multispectral imaging and a large, clinically validated database. This collaboration seeks to enhance patient care and familiarize Australian clinicians with the DeepView System, leveraging PolyNovo’s established presence in burn wound therapy.
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.
FAQ
What is Spectral AI focused on?
What is the significance of the DeepView System?
What recent achievement did Spectral AI have?
Who is Louis Percoco?
What does TMAC aim to achieve?
