Spectral AI Reaches 50% Enrollment at Burn Centers for U.S. Pivotal Burn Study
Spectral AI, Inc. - Class A (MDAI)
Company Research
Source: GlobeNewswire
DALLAS, June 06, 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 it has achieved 50% clinical trial site enrollment at burn centers for its 2024 pivotal study designed to validate the algorithm used by its DeepView™ System for burn indication. This pivotal study, which is targeting enrollment of 240 patients, including both adult and pediatric subjects at multiple burn centers and emergency departments across the U.S., is expected to be the final clinical trial before seeking FDA approval in 2025. The completion of the pivotal study will address two primary objectives. First, the study will validate the standalone performance of the DeepView™ System’s algorithm on an independent dataset, further solidifying its objective utility in clinical practice. Second, the study will compare the
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MDAI
Sec Filings
- 6/24/24 - Form 8-K
- 6/5/24 - Form 8-K
- 5/17/24 - Form 4
- MDAI's page on the SEC website