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) announces the return of founder Dr. J. Michael DiMaio as Chairman of the Board of Directors. The company, focused on AI-driven medical diagnostics for wound care, aims to enhance its leadership for the next growth stage. Richard Cotton will remain on the Board as Audit Committee head and Lead Independent Director.
Dr. DiMaio, a cardiothoracic surgeon with over 30 years of experience, brings extensive medical expertise and leadership to his role. The company has formed an Office of the Chairman to manage daily operations and support the development and commercialization of the DeepView® System. This office will focus on engagement with BARDA, FDA, commercialization efforts, and strategic relationships.
In this transition, Peter Carlson will step down as CEO and Board member but continue as a consultant. Spectral AI remains committed to advancing AI-driven healthcare solutions, including opportunities through its subsidiary, Spectral IP, Inc.
Spectral AI (Nasdaq: MDAI) has completed a proof-of-concept for its wound measurement technology that calculates the total body surface area (TBSA) of burns. This technology, integrated into the DeepView® System for burn indication (DeepView AI®-Burn), provides fast, accurate, and standardized measurements to improve patient treatment decisions.
Unlike current methods, Spectral AI's technology utilizes image capture to deliver distance, area, and volume measurements with sub-millimetric accuracy, without manual markers. It generates burn size and depth calculations in seconds, aiding clinicians in treatment decisions. The company believes this technology offers a more comprehensive representation of acute burn injuries and could potentially change the standard of care in burn wound treatment.
Spectral AI (Nasdaq: MDAI) has reached 25% patient enrollment at Emergency Departments (EDs) for its U.S. Burn Pivotal Study. The company has also added two new ED Clinical Trial Sites: MedStar Washington Hospital Center and the University of Utah, expanding participating EDs to 11 facilities. This study aims to validate the AI-driven algorithm used by Spectral AI's DeepView® System for burn indication.
The company has completed adult and pediatric patient enrollment at U.S. burn centers for the study. Spectral AI plans to submit a De Novo request to the FDA in Q2 2025, seeking classification of DeepView AI®-Burn as a Class II medical device. The DeepView® System is designed to provide immediate predictions of wound healing on Day One, supporting clinical decision-making for burn treatment plans.
Spectral AI (Nasdaq: MDAI) has outlined its regulatory strategy to enter the U.S. market with DeepView AI®-Burn, a predictive medical device for burn assessment. The company plans to pursue a De Novo submission to the FDA, requesting classification as a Class II medical device. This decision is based on the unique characteristics of DeepView AI®-Burn, which received Breakthrough Device Designation in 2018.
The device combines multi-spectral imaging with AI to assess burn healing potential, trained on over 340 billion clinically validated data points. Spectral AI expects to submit the De Novo request in Q2 2025. The company recently completed patient enrollment for its U.S. Burn Pivotal Study, marking a significant milestone in its development process.
Spectral AI (Nasdaq: MDAI) highlights a study by the American Burn Association (ABA) revealing inequities in access to specialized burn care. The study shows rural and pediatric patients face significant barriers to timely treatment. Key findings include:
1. Pediatric patients travel 30.5 miles further than adults to burn centers, increasing transport costs.
2. Rural patients face 50.02% longer travel distances and nearly double transportation costs.
3. Mountain West and Southeastern U.S. have critically low access to burn centers.
Spectral AI's DeepView® System aims to address these disparities by providing rapid, objective burn wound assessments. The company recently completed enrollment for its U.S. Burn Pivotal Study and plans to submit a De Novo classification request to the FDA in Q2 2025.
Spectral AI (Nasdaq: MDAI) has received an additional $850,000 award from the Medical Technology Enterprise Consortium (MTEC) to support the development of DeepView SnapShot M®, a handheld predictive burn wound healing device for battlefield assessment. This brings the total non-dilutive government funding for the project to over $7.0 million.
DeepView SnapShot M® is designed to provide quick and accurate wound assessment in combat zones and military hospitals, aligning with MTEC's mission to protect and optimize U.S. military personnel health. The device is based on Spectral AI's DeepView™ System platform, which uses multispectral imaging and an AI-driven algorithm trained on over 340 billion clinically validated data points to assess burn wound healing potential.
Spectral AI (Nasdaq: MDAI), an AI company specializing in medical diagnostics for wound care, has announced its participation in two upcoming investor conferences in New York City. Peter M. Carlson, CEO, and Vince Capone, CFO, will represent the company at these events:
1. H.C. Wainwright 26th Annual Global Investment Conference (September 9-11, 2024): A virtual fireside chat will be available from September 9 at 7:00 am ET, accessible via the company's website. One-on-one meetings will be held throughout the day.
2. Lake Street BIG8 Investor Conference (September 12, 2024): The company will participate in one-on-one meetings throughout the day.
These conferences provide Spectral AI with opportunities to engage with investors and showcase their AI-driven medical diagnostics technology for wound care treatment decisions.
Spectral AI (Nasdaq: MDAI) has completed adult and pediatric patient enrollment at U.S. burn centers for its U.S. Burn Pivotal Study, one of the largest domestic burn studies ever conducted. This milestone advances the commercialization timeline for the company's DeepView™ System for burn indication. The study aims to validate the AI-driven algorithm used by DeepView™, which assesses burn healing potential using multi-spectral imaging and a proprietary database of over 340 billion clinically validated data points.
Spectral AI plans to submit a De Novo classification request to the FDA in Q2 2025 for the use of DeepView™ in burn centers. The system has shown superior accuracy in assessing burn wounds compared to current standards. The company is continuing to enroll patients at Emergency Departments, with a subsequent 510(k) application planned for ED use following FDA approval for burn centers.
Spectral AI (Nasdaq: MDAI) announced a podium presentation at the BBA/ISBI Joint Conference by Dr. Jeffrey Carter, showcasing data from an ongoing study on their DeepView™ System. This AI-driven technology uses multispectral imaging to assess burn wound severity with accuracy exceeding experienced physicians. The presentation highlights the potential of DeepView™ to address challenges in burn care, including resources and the need for accurate diagnoses.
The company's 2024 U.S. Burn Pivotal Study is ongoing, aiming to validate the AI algorithm before seeking FDA approval in 2025. Spectral AI believes their system can significantly impact the speed, treatment, and outcomes for acute burn wound patients, especially in mass casualty events where current healthcare systems face constraints.
Spectral AI (NASDAQ: MDAI) reported Q2 2024 financial results, highlighting $7.5 million in Research & Development Revenue, a 76% increase from Q2 2023. The company's U.S. Burn Pivotal Study has exceeded 85% enrollment, paving the way for FDA submission in early 2025. Spectral AI maintains a cash position of $6.9 million and is on track to generate its first commercial revenues in the U.K. later this year.
Key developments include:
- Progress in handheld burn wound diagnostic technology
- Collaboration with PolyNovo for Australian market entry
- Addition to Russell Microcap® Index
- Deployment of five DeepView Burn devices in the U.K.
The company reiterates its FY 2024 revenue guidance of approximately $28.0 million.
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