Spectral AI Announces Last Patient Out in U.S. Burn Pivotal Study at Burn Centers
Spectral AI, Inc. - Class A (MDAI)
Company Research
Source: GlobeNewswire
Milestone Achievement Supports Planned FDA Submission of DeepView AI®-Burn in 2025 DALLAS, Oct. 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 final group of burn center patients in the Company’s U.S. Burn Pivotal Study have successfully completed their clinical visits. One of the largest domestic burn center studies ever conducted, the U.S. Burn Pivotal Study is expected to be the final clinical trial before the Company seeks U.S. Food and Drug Administration (“FDA”) approval of its DeepView® System for burn indication (“DeepView AI®-Burn”) in the first half of 2025. DeepView AI®-Burn is a non-invasive, predictive medical device designed to distinguish between healing and non-healing tissue in order to provide clinicians with an immediate and binary assessment of a burn woun
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MDAI
News
- Spectral AI Schedules 2024 Third Quarter Financial Results and Conference CallGlobeNewswire
- Spectral AI, Inc. Announces Return of Founder Dr. J. Michael DiMaio as Chairman of the Board of DirectorsGlobeNewswire
- Spectral AI Completes Proof of Concept for Wound Measurement TechnologyGlobeNewswire
- 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
MDAI
Earnings
- 8/12/24 - Miss
MDAI
Sec Filings
- 10/16/24 - Form S-3
- 10/15/24 - Form 8-K
- 8/13/24 - Form 8-K
- MDAI's page on the SEC website