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Spectral AI Inc.

2.12

-0.0100-0.47%

Post-market: 2.12-0.0002-0.01%19:53 EDT

Volume:207.51K

Turnover:436.91K

Market Cap:54.58M

PE:-4.36

High:2.16

Open:2.13

Low:2.07

Close:2.13

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Overview Company News Filings

Spectral AI Announces Successful Results From Its Burn Validation Study of the Deepview System

THOMSON REUTERS

Spectral AI Inc - Plans FDA Submission by Mid-2025 for De Novo Clearance

THOMSON REUTERS

Spectral AI Announces Successful Results from its Burn Validation Study of the DeepView System

Spectral AI Completes Three Device Installations in Australia

Spectral AI Schedules 2024 Fourth Quarter and Full Year Financial Results and Conference Call

Spectral AI Strengthens Financial Position Ahead of FDA Submission

THOMSON REUTERS

Press Release: Spectral AI Strengthens Financial Position Ahead of FDA Submission

MDAI: Pivotal Data Analysis Complete

Zacks Small Cap Research

Northland Securities Sticks to Their Buy Rating for Spectral AI (MDAI)

Spectral AI Completes Data Analysis for U.S. Burn Pivotal Study

BRIEF-Spectral AI To Pursue De Novo Classification From FDA For Use Of Deepview System

Spectral AI Completes Pediatric Enrollment in Burn Treatment Study in US

MT Newswires Live

Spectral AI completes enrollment in U.S. Burn Pivotal Study

Spectral AI Completes Pediatric Enrollment in Emergency Departments for U.S. Burn Pivotal Study

THOMSON REUTERS

Spectral AI: to Pursue De Novo Classification From FDA for Use of Deepview System, Expects to Submit Request in H1 2025

THOMSON REUTERS

Spectral AI Completes Pediatric Enrollment in Emergency Departments for U.S. Burn Pivotal Study

Spectral AI sees FY24 revenue exceeding $28M, consensus $28.65M

Spectral AI Inc - Anticipates Reporting Annual Revenue Exceeding Its $28 Mln Market Guidance

THOMSON REUTERS

Spectral AI Provides Update to Investors

THOMSON REUTERS

Spectral AI Provides Update to Investors

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Plans FDA Submission by Mid-2025 for De Novo Clearance","url":"https://stock-news.laohu8.com/highlight/detail?id=2520549134","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2520549134?lang=en_us&edition=fundamental","pubTime":"2025-03-17 19:07","pubTimestamp":1742209622,"startTime":"0","endTime":"0","summary":null,"market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250317:nFWN3Q00PB:2","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["MDAI","BK4082"],"gpt_icon":0},{"id":"2520549393","title":"Spectral AI Announces Successful Results from its Burn Validation Study of the DeepView System","url":"https://stock-news.laohu8.com/highlight/detail?id=2520549393","media":"GlobeNewswire","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2520549393?lang=en_us&edition=fundamental","pubTime":"2025-03-17 19:00","pubTimestamp":1742209200,"startTime":"0","endTime":"0","summary":"DeepView System outperforms burn physicians in identifying non-healing tissue. Landmark Burn Validation Study, one of the largest in U.S. history, confirms DeepView’s performance. Spectral AI plans FDA submission by mid-2025, targeting De Novo Clearance and rapid commercialization to transform burn care. Sensitivity: The DeepView System demonstrated a statistically significant improvement in identifying non-healing tissue compared to burn physicians, as judged on sensitivity. At the image-wise level, the DeepView System scored 86.6% while clinical judgment annotation  of burn physicians scored 40.8%. At the pixel-wise level, the DeepView System scored 81.9% and CJA of burn physicians scored 38.8%.Dice Score: The DeepView System achieved statistically significant higher Dice Scores when compared to those derived from burn physicians’ CJA, representing the improved pixel-wise evaluation between predicated and true segmented wound areas with the D","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/spectral-ai-announces-successful-results-110000579.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["MDAI","MDAIW","BK4082"],"gpt_icon":0},{"id":"2517942164","title":"Spectral AI Completes Three Device Installations in Australia","url":"https://stock-news.laohu8.com/highlight/detail?id=2517942164","media":"GlobeNewswire","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2517942164?lang=en_us&edition=fundamental","pubTime":"2025-03-06 23:36","pubTimestamp":1741275360,"startTime":"0","endTime":"0","summary":"DALLAS, March  06, 2025  (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) (“Spectral AI” or the “Company”), developer of the AI-driven DeepView System, which received Breakthrough Device Designation fro","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.globenewswire.com/news-release/2025/03/06/3038363/0/en/Spectral-AI-Completes-Three-Device-Installations-in-Australia.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["MDAI","BK4082"],"gpt_icon":0},{"id":"2514132329","title":"Spectral AI Schedules 2024 Fourth Quarter and Full Year Financial Results and Conference Call","url":"https://stock-news.laohu8.com/highlight/detail?id=2514132329","media":"GlobeNewswire","labels":["conferences"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2514132329?lang=en_us&edition=fundamental","pubTime":"2025-02-28 21:00","pubTimestamp":1740747600,"startTime":"0","endTime":"0","summary":"DALLAS, Feb. 28, 2025  -- Spectral AI  , developer of the AI-driven DeepView System, which received Breakthrough Device Designation from the U.S. Food and Drug Administration  in 2018 and uses multi-spectral imaging and AI algorithms to predict burn healing potential, today announced that it will report financial results for the fourth quarter and full year ended December 31, 2024 on Wednesday, March 27, 2025 after the close of the stock market. The Company will host a corresponding conference call at 5:00 pm Eastern Time to discuss the results.Investors interested in participating in the live call can dial:. These forward-looking statements are not guarantees of future performance, conditions or results, and involve a number of known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside Company’s control, that could cause actual results or outcomes to differ materially from those discussed in the forward-looking statements. As such, reade","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/spectral-ai-schedules-2024-fourth-130000247.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"conferences","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4082","MDAIW","MDAI"],"gpt_icon":0},{"id":"2512769156","title":"Spectral AI Strengthens Financial Position Ahead of FDA Submission","url":"https://stock-news.laohu8.com/highlight/detail?id=2512769156","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512769156?lang=en_us&edition=fundamental","pubTime":"2025-02-18 20:00","pubTimestamp":1739880003,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250218:nTUA6SL8C5:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4082","MDAI","MDAIW"],"gpt_icon":0},{"id":"2512156032","title":"Press Release: Spectral AI Strengthens Financial Position Ahead of FDA Submission","url":"https://stock-news.laohu8.com/highlight/detail?id=2512156032","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2512156032?lang=en_us&edition=fundamental","pubTime":"2025-02-18 20:00","pubTimestamp":1739880000,"startTime":"0","endTime":"0","summary":"DALLAS, Feb. 18, 2025  -- Spectral AI  , developer of the AI-driven DeepView System, which received Breakthrough Device Designation from the U.S. Food and Drug Administration  in 2018 and uses multi-spectral imaging and AI algorithms to predict burn healing potential, today announced the satisfaction of its final remaining obligations under the Company's debt facility with Yorkville Advisors. The Company retains access to additional financing of up to $17.5 million under an existing standby equity purchase agreement.\"I am pleased to share this milestone as we continue advancing toward our FDA submission and work to bring our technology to burn care institutions across the U.S.,\" said Dr. J. Michael DiMaio, MD, Chairman of the Board at Spectral AI.","market":"hk","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["MDAI","BK4232","BK4082","BK4022","R"],"gpt_icon":0},{"id":"2511104956","title":"MDAI: Pivotal Data Analysis Complete","url":"https://stock-news.laohu8.com/highlight/detail?id=2511104956","media":"Zacks Small Cap Research","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2511104956?lang=en_us&edition=fundamental","pubTime":"2025-02-15 00:07","pubTimestamp":1739549220,"startTime":"0","endTime":"0","summary":"Since reporting third quarter results in November, Spectral AI, Inc.  has continued to advance its burn program in burn center populations, pediatric burn in emergency departments and with the SnapShot M portable device. Most importantly, Spectral has finished enrollment and evaluation of all patents in the burn center trial and has completed its analysis of the related pivotal data. This achievement places the company in position to make a De Novo submission by June 2025. The pediatric study at emergency departments completed enrollment in January and will follow closely behind the emergency department burn study in terms of regulatory pathway. The portable DeepView SnapShot M is also advancing with feedback from Army stakeholders.","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/mdai-pivotal-data-analysis-complete-160700147.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["MDAIW","TBSA","BK4082","MDAI"],"gpt_icon":0},{"id":"2510850244","title":"Northland Securities Sticks to Their Buy Rating for Spectral AI (MDAI)","url":"https://stock-news.laohu8.com/highlight/detail?id=2510850244","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2510850244?lang=en_us&edition=fundamental","pubTime":"2025-02-10 22:06","pubTimestamp":1739196391,"startTime":"0","endTime":"0","summary":"In a report released today, Carl Byrnes from Northland Securities maintained a Buy rating on Spectral AI (MDAI – Research Report), with a price tar...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/northland-securities-sticks-to-their-buy-rating-for-spectral-ai-mdai?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/blurbs/northland-securities-sticks-to-their-buy-rating-for-spectral-ai-mdai?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["MDAI"],"gpt_icon":0},{"id":"2509745564","title":"Spectral AI Completes Data Analysis for U.S. Burn Pivotal Study","url":"https://stock-news.laohu8.com/highlight/detail?id=2509745564","media":"GlobeNewswire","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2509745564?lang=en_us&edition=fundamental","pubTime":"2025-02-07 21:21","pubTimestamp":1738934460,"startTime":"0","endTime":"0","summary":"DALLAS, Feb. 07, 2025  -- Spectral AI  , developer of the AI-driven DeepView System, which received Breakthrough Device Designation from the U.S. Food and Drug Administration  in 2018 and uses multi-spectral imaging and AI algorithms to predict burn healing potential, today announced the completion of its data analytics 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 its burn indication. Spectral AI's DeepView System is a predictive medical device and associated software that assesses the healing potential of burn wounds by combining multispectral imaging with an AI-driven algorithm trained and tested against a proprietary database of more than 340 billion clinically-validated data points. By distinguishing between healing and non-healing tissue, the DeepView System provides an immediate and binary prediction of wound healing on","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/spectral-ai-completes-data-analysis-132100867.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4082","MDAI","MDAIW"],"gpt_icon":0},{"id":"2507054837","title":"BRIEF-Spectral AI To Pursue De Novo Classification From FDA For Use Of Deepview System","url":"https://stock-news.laohu8.com/highlight/detail?id=2507054837","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2507054837?lang=en_us&edition=fundamental","pubTime":"2025-01-29 00:04","pubTimestamp":1738080290,"startTime":"0","endTime":"0","summary":"BRIEF-Spectral AI To Pursue De Novo Classification From FDA For Use Of Deepview SystemJan 28 (Reuters) - Spectral AI Inc MDAI.O:SPECTRAL AI COMPLETES PEDIATRIC ENROLLMENT IN EMERGENCY DEPARTMENTS FOR ","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250128:nFWN3OO17C:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["MDAI","BK4082"],"gpt_icon":0},{"id":"2506517111","title":"Spectral AI Completes Pediatric Enrollment in Burn Treatment Study in US","url":"https://stock-news.laohu8.com/highlight/detail?id=2506517111","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2506517111?lang=en_us&edition=fundamental","pubTime":"2025-01-28 23:34","pubTimestamp":1738078443,"startTime":"0","endTime":"0","summary":"Spectral AI  said Tuesday it has completed its pediatric enrollment at US emergency departments for its burn treatment pivotal study.The study aims to validate the artificial intelligence-driven algorithm used by the company's DeepView System, a device that uses multi-spectral imaging and algorithms to predict burn healing potential, according to the company.Spectral AI said it plans to use the results of the study to support its De Novo classification request, expected to be submitted to the US Food and Drug Administration within H1.Price: 1.79, Change: +0.03, Percent Change: +1.65","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["MDAI","BK4082"],"gpt_icon":0},{"id":"2506514772","title":"Spectral AI completes enrollment in U.S. Burn Pivotal Study","url":"https://stock-news.laohu8.com/highlight/detail?id=2506514772","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2506514772?lang=en_us&edition=fundamental","pubTime":"2025-01-28 22:51","pubTimestamp":1738075869,"startTime":"0","endTime":"0","summary":"Spectral AI (MDAI) announced the completion of its pediatric enrollment at U.S. emergency departments for its U.S. Burn Pivotal Study. 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