Spectral AI Completes Burn Center Enrollment for U.S. Burn Pivotal Study
Spectral AI, Inc. - Class A (MDAI)
Company Research
Source: GlobeNewswire
DALLAS, Aug. 27, 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 the completion of 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, the U.S. Burn Pivotal Study is designed to validate the AI-driven algorithm used by the Company’s DeepView™ System for burn indication. Using data from these burn center patients, the Company will pursue a De Novo classification from the U.S. Food and Drug Administration (“FDA”) for use of the DeepView™ System in burn centers and expects to submit the request in the second quarter of 2025. “We met our burn center enrollment goal much sooner than anticipated due to the dedication of our team and the support of study participants,” said Peter M. Carlson, Chief Ex
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News
- Spectral AI Achieves 25% Patient Enrollment at Emergency Departments for U.S. Burn Pivotal Study and Adds Two New Clinical Trial SitesGlobeNewswire
- Spectral AI Outlines U.S. Regulatory Pathway for DeepView® System for Burn IndicationGlobeNewswire
- American Burn Association Study Highlights Inequities in Access to Specialized Burn CareGlobeNewswire
- Spectral AI Awarded Additional Funding from Medical Technology Enterprise Consortium to Support Ongoing Development of DeepView SnapShot M®GlobeNewswire
- Spectral AI to Participate in Upcoming Investor ConferencesGlobeNewswire
MDAI
Earnings
- 8/12/24 - Miss
MDAI
Sec Filings
- 8/13/24 - Form 8-K
- 8/12/24 - Form 10-Q
- 7/15/24 - Form 8-K
- MDAI's page on the SEC website