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Spectral AI Reports Over 511 Days of Expert Engagement in DeepView System Validation for FDA Submission

Spectral AI Reports Over 511 Days of Expert Engagement in DeepView System Validation for FDA Submission

Spectral AI 報告在 DeepView 系統驗證中進行了超過 511 天的專家參與,以便提交給 FDA。
Quiver Quantitative ·  12/12 21:13

Spectral AI reports significant physician engagement for DeepView training, enhancing its AI-based burn healing prediction system.

Spectral AI報告說,醫生對DeepView訓練的參與度很高,從而增強了其基於人工智能的燒傷癒合預測系統。

Quiver AI Summary

Quiver AI 摘要

Spectral AI, a developer of the AI-driven DeepView System for predicting burn healing, announced that national burn care leaders contributed over 511 in-person days to train and validate the system for FDA submission, alongside an additional 250 days for Proof-of-Concept studies. Esteemed participants include prominent members of the American Burn Association and leading medical journals, highlighting a significant collaborative effort to enhance the system's credibility and effectiveness. The DeepView technology combines advanced imaging with artificial intelligence to assess wound healing potential, receiving FDA Breakthrough Device Designation in 2018 and the UKCA mark earlier this year. This system aims to improve patient outcomes in wound care by delivering objective assessments and reducing healthcare costs.

Spectral AI是人工智能驅動的用於預測燒傷癒合的DeepView系統的開發商。該公司宣佈,國家燒傷護理領導者投入了超過511天的面對面培訓和驗證該系統,以供FDA提交,另外還提供了250天的時間用於概念驗證研究。尊敬的參與者包括美國燒傷協會和領先醫學期刊的知名會員,他們重點介紹了爲提高該系統的可信度和有效性所做的重大合作努力。DeepView技術將先進的成像與人工智能相結合,以評估傷口癒合潛力,於2018年獲得美國食品藥品管理局突破性設備稱號,今年早些時候獲得UKCA標誌。該系統旨在通過提供客觀的評估和降低醫療成本,改善患者在傷口護理方面的預後。

Potential Positives

潛在的積極因素

  • Significant engagement from national leaders in burn care, with over 511 in-person days dedicated to the training and validation of the DeepView System, indicating strong professional support and validation of the technology.
  • The collaboration includes esteemed professionals, such as three current or former presidents of the American Burn Association, enhancing the credibility and reliability of the training process.
  • DeepView has previously received Breakthrough Device Designation from the U.S. FDA, underscoring its potential impact in medical diagnostics and patient care.
  • The achievement of the UK Conformity Assessed (UKCA) mark for burn indications expands the potential market and acceptance of DeepView in international markets.
  • 國家領導者積極參與燒傷護理,超過511天專門用於DeepView系統的培訓和驗證,這表明該技術得到了強有力的專業支持和驗證。
  • 此次合作包括受人尊敬的專業人士,例如美國燒傷協會的三位現任或前任主席,從而提高了培訓過程的可信度和可靠性。
  • DeepView此前已獲得美國食品藥品管理局的突破性設備認證,這突顯了其對醫療診斷和患者護理的潛在影響。
  • 燒傷指示的英國合規性評估(UKCA)標誌的獲得擴大了潛在市場和DeepView在國際市場的接受度。

Potential Negatives

潛在的負面因素

  • The press release emphasizes the extensive engagement of national leaders in burn care, which might raise concerns about the adequacy of internal expertise within Spectral AI.
  • The mention of "forward-looking statements" and associated risks may indicate instability or uncertainty in the company's future performance, potentially deterring investors.
  • There is a significant focus on collaborations and external validation, which may imply that the company's technology is not yet independently proven or commercially viable.
  • 新聞稿強調了國家領導人對燒傷護理的廣泛參與,這可能會引起人們對Spectral AI內部專業知識是否充足的擔憂。
  • 提及 「前瞻性陳述」 和相關風險可能表明公司未來業績的不穩定性或不確定性,可能會使投資者望而卻步。
  • 人們非常關注合作和外部驗證,這可能意味着該公司的技術尚未得到獨立驗證或商業可行性。

FAQ

常見問題

What is the DeepView System developed by Spectral AI?

Spectral AI 開發的 DeepView 系統是什麼?

The DeepView System is an AI-driven wound diagnostics platform that predicts burn healing potential using multi-spectral imaging and advanced algorithms.

DeepView 系統是一個人工智能驅動的傷口診斷平台,可使用多光譜成像和高級算法預測燒傷癒合潛力。

How many physician engagement days were dedicated to the DeepView training?

有多少醫生參與了 DeepView 培訓?

Over 511 in-person days of physician engagement were dedicated to training and validation studies for the DeepView System.

超過511天的醫生面對面參與了專門用於DeepView系統的培訓和驗證研究。

What recognition did DeepView receive from the FDA?

DeepView 獲得了美國食品藥品管理局的哪些認可?

DeepView received Breakthrough Device Designation from the U.S. FDA in 2018, marking its significance in medical diagnostics.

DeepView於2018年獲得了美國食品藥品管理局的突破性設備認證,這標誌着其在醫療診斷中的重要性。

Who contributed to the validation studies for DeepView?

誰爲 DeepView 的驗證研究做出了貢獻?

National leaders in burn care, including presidents and board members of the American Burn Association, contributed to the validation studies.

燒傷護理領域的國家領導人,包括美國燒傷協會主席和董事會成員,爲驗證研究做出了貢獻。

What are the initial applications of DeepView technology?

DeepView 技術的最初應用是什麼?

The initial applications of DeepView technology focus on wound care, particularly for patients with burns and diabetic foot ulcers.

DeepView技術的最初應用側重於傷口護理,特別是燒傷和糖尿病足潰瘍患者。

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

免責聲明:這是由人工智能生成的 GlobeNewswire 發佈的新聞稿摘要。用於總結此版本的模型可能會出錯。在此處查看完整版本。


$MDAI Hedge Fund Activity

$MDAI 對沖基金活動

We have seen 12 institutional investors add shares of $MDAI stock to their portfolio, and 10 decrease their positions in their most recent quarter.

我們已經看到12家機構投資者在其投資組合中增加了$MDAI股票的股票,10家機構投資者在最近一個季度減少了頭寸。

Here are some of the largest recent moves:

以下是近期一些最大的走勢:

  • MORGAN STANLEY added 110,727 shares (+3261.5%) to their portfolio in Q3 2024
  • AVANTAX PLANNING PARTNERS, INC. added 95,493 shares (+148.4%) to their portfolio in Q3 2024
  • VANGUARD GROUP INC added 43,872 shares (+71.3%) to their portfolio in Q3 2024
  • MURCHINSON LTD. removed 40,000 shares (-100.0%) from their portfolio in Q2 2024
  • UBS GROUP AG added 39,105 shares (+3910500.0%) to their portfolio in Q3 2024
  • GEODE CAPITAL MANAGEMENT, LLC added 29,527 shares (+43.9%) to their portfolio in Q3 2024
  • MYDA ADVISORS LLC removed 20,000 shares (-100.0%) from their portfolio in Q2 2024
  • 摩根士丹利在2024年第三季度在其投資組合中增加了110,727股股票(+3261.5%)
  • AVANTAX PLANNING PARTNERS, INC. 在 2024 年第三季度在其投資組合中增加了 95,493 股(+148.4%)
  • VANGUARD GROUP INC 在 2024 年第三季度在其投資組合中增加了 43,872 股(+71.3%)
  • 默欽森有限公司在2024年第二季度從其投資組合中刪除了4萬股股票(-100.0%)
  • 瑞銀集團股份公司在2024年第三季度在其投資組合中增加了39,105股股票(+3910500.0%)
  • GEODE CAPITAL Management, LLC 在 2024 年第三季度在其投資組合中增加了 29,527 股(+43.9%)
  • MYDA ADVISORS LLC 在 2024 年第二季度從其投資組合中刪除了 20,000 股股票(-100.0%)

To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.

要追蹤對沖基金的股票投資組合,請查看Quiver Quantization的機構持股儀表板。

Full Release

完整版本



DALLAS, Dec. 12, 2024 (GLOBE NEWSWIRE) -- Spectral AI (NASDAQ: MDAI) ("Spectral AI" or the "Company"), developer of the AI-driven DeepView



System, which received Breakthrough Device Designation from the U.S. FDA in 2018, that uses multi-spectral imaging and algorithms to predict burn healing potential, today announced that national leaders in burn care have dedicated more than an estimated 511 in-person days of physician engagement to the training and validation studies for the DeepView System for U.S. Food and Drug Administration (FDA) submission. This does not include more than an estimated 250 additional days that these experts devoted in Proof-of-Concept studies.


達拉斯,2024年12月12日(環球新聞專線)——Spectral AI(納斯達克股票代碼:MDAI)(「Spectral AI」 或 「公司」),人工智能驅動的DeepView的開發者



該系統於2018年獲得了美國食品藥品監督管理局(FDA)頒發的突破性設備認定,該系統使用多光譜成像和算法來預測燒傷癒合潛力。該系統今天宣佈,燒傷護理領域的全國領導者已經投入了超過511天的醫生面對面參與美國食品藥品監督管理局(FDA)申報的培訓和驗證研究。這不包括這些專家在概念驗證研究上投入的估計額外天數超過250天。



This extraordinary collaboration includes participation from physicians across the country who are national leaders in burn care. They include three current or former presidents, and ten board members/past board members of the national burn organization, the American Burn Association, and two editors-in-chief of leading medical burn journals. This level of participation by such esteemed professionals represents an unprecedented investment of time and expertise to work with Spectral AI's team to develop artificial intelligence algorithm.


這種非凡的合作包括全國各地燒傷護理領域的全國領先醫生的參與。他們包括三位現任或前任主席、全國燒傷組織美國燒傷協會的十位董事會成員/前任董事會成員,以及兩位主要醫學燒傷期刊的主編。這些受人尊敬的專業人士的這種參與水平代表了與Spectral AI團隊合作開發人工智能算法所花費的時間和專業知識前所未有的投入。



Spectral AI's patented DeepView



technology is an AI-driven wound diagnostics platform that combines advanced algorithms with medical imaging to predict wound healing potential that has been Breakthrough Designated by the FDA. The platform relies on a specialized dataset, allowing it to identify critical patterns and deliver compelling clinical insights. This unique collaboration with a world-class team of burn experts enhances the dataset's credibility and reliability as well as underscores the study's groundbreaking nature.


Spectral AI 的專利 Deep



技術是一個由人工智能驅動的傷口診斷平台,它將先進的算法與醫學成像相結合,預測傷口癒合潛力,該傷口癒合潛力已獲得 FDA 的突破性認定。該平台依賴於專業的數據集,使其能夠識別關鍵模式並提供令人信服的臨床見解。與世界一流的燒傷專家團隊的這種獨特合作增強了數據集的可信度和可靠性,也凸顯了該研究的開創性質。



"This level of cooperation represents an unprecedented amount of time and effort for national leaders in burn care," said Dr. Jeffrey Carter, M.D., Principal Investigator of the studies. "We are deeply grateful for the leadership of Dr. Michael DiMaio and the engagement of this exceptional group of clinicians."


這些研究的首席研究員傑弗裏·卡特萬博士說:「這種合作水平代表着燒傷護理領域的國家領導者前所未有的時間和精力。」「我們對邁克爾·迪馬約博士的領導以及這群傑出的臨床醫生的參與深表感謝。」



Dr. Michael DiMaio, Chairman of Spectral AI's board of directors, added, "I am extremely proud of our Spectral AI team and the fact that we have been able to include some of our country's most highly regarded burn experts in DeepView's training and validation study. These experts allow the algorithm to be trained by the best-in-class clinicians with countless years of experience. This joint effort reflects our unwavering commitment to ensuring the DeepView



System becomes a gold-standard tool in burn care."


Spectral AI董事會主席Michael DiMaio博士補充說:“我爲我們的Spectral AI團隊感到非常自豪,因爲我們能夠將我國一些最受尊敬的燒傷專家納入DeepView的培訓和驗證研究。這些專家使該算法可以由具有無數年經驗的一流臨床醫生進行訓練。這種共同努力反映了我們對確保 DeepView 的堅定承諾



系統成爲燒傷護理的黃金標準工具。”



DeepView



received a significant endorsement in 2018 when it was granted the Breakthrough Device Designation from the U.S. FDA. This recognition, coupled with the achievement of the United Kingdom Conformity Assessed (UKCA) mark for burn indications earlier this year, positions DeepView



as a potential game-changer in medical diagnostics.


深度視圖



2018 年,它獲得了美國 FDA 頒發的突破性設備稱號,獲得了重大認可。這一認可,加上今年早些時候在燒傷指示方面獲得的英國合格評估(UKCA)標誌,使DeepView站穩了腳跟



作爲醫療診斷領域潛在的遊戲規則改變者。




About Spectral AI



關於光譜人工智能



Spectral AI, Inc. is a Dallas-based predictive AI company focused on medical diagnostics for faster and more accurate treatment decisions in wound care, with initial applications involving patients with burns and diabetic foot ulcers. The Company is working to revolutionize the management of wound care by "Seeing the Unknown



" with its DeepView



System. DeepView is a predictive device that offers clinicians an objective and immediate assessment of a wound's healing potential prior to treatment or other medical intervention. With algorithm-driven results and a goal of exceeding the current standard of care in the future, DeepView is expected to provide faster and more accurate treatment insight towards value care by improving patient outcomes and reducing healthcare costs. For more information about DeepView, visit



.


Spectral AI, Inc. 是一家總部位於達拉斯的預測性人工智能公司,專注於醫學診斷,以便在傷口護理中做出更快、更準確的治療決策,最初的應用涉及燒傷和糖尿病足潰瘍患者。該公司正努力通過 「看見未知」 來徹底改變傷口護理的管理



“憑藉其 DeepView



系統。DeepView是一種預測設備,可讓臨床醫生在治療或其他醫療干預之前客觀而即時地評估傷口的癒合潛力。憑藉算法驅動的結果,以及未來超越當前護理標準的目標,DeepView有望通過改善患者預後和降低醫療成本,爲價值護理提供更快、更準確的治療見解。有關 DeepView 的更多信息,請訪問



.




Forward-Looking Statements



前瞻性陳述



Certain statements made in this release are "forward looking statements" within the meaning of the "safe harbor" provisions of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the Company's intention to separate its Spectral IP subsidiary from the Company, and each Company's strategy, plans, objectives, initiatives, strategic goals, financial outlook or other non-historical matters. When used in this press release, the words "estimates," "projected," "expects," "anticipates," "forecasts," "plans," "intends," "believes," "seeks," "may," "will," "should," "future," "propose" and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements.


本新聞稿中的某些聲明是1995年《美國私人證券訴訟改革法》「安全港」 條款所指的 「前瞻性陳述」,包括有關公司打算將其Spectral IP子公司與公司分開的聲明,以及每家公司的戰略、計劃、目標、舉措、戰略目標、財務前景或其他非歷史事項的聲明。在本新聞稿中使用時,「估計」、「預測」、「預期」、「預測」、「計劃」、「打算」、「相信」、「尋求」、「可能」、「將」、「應該」、「未來」、「提議」 等詞語以及這些詞語或類似表述的變體(或此類詞語或表達的否定版本)旨在識別前瞻性陳述。



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, readers are cautioned not to place undue reliance on any forward-looking statements.


這些前瞻性陳述不能保證未來的業績、狀況或結果,涉及許多已知和未知的風險、不確定性、假設和其他重要因素,其中許多因素是公司無法控制的,可能導致實際業績或結果與前瞻性陳述中討論的結果存在重大差異。因此,提醒讀者不要過分依賴任何前瞻性陳述。



Investors should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" sections of the Company's filings with the SEC, including the Registration Statement and the other documents filed by the Company. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Spectral AI undertakes no obligation to update any forward-looking statements except as otherwise required by law.


投資者應仔細考慮公司向美國證券交易委員會提交的文件中 「風險因素」 部分中描述的上述因素以及其他風險和不確定性,包括註冊聲明和公司提交的其他文件。這些文件確定並解決了其他重要的風險和不確定性,這些風險和不確定性可能導致實際事件和結果與前瞻性陳述中包含的事件和結果存在重大差異。除非法律另有要求,否則Spectral AI沒有義務更新任何前瞻性陳述。



For Media and Investor Relations, please contact:


如需媒體和投資者關係,請聯繫:



David Kugelman
Atlanta Capital Partners LLC
(866) 692-6847 Toll Free - U.S. & Canada
(404) 281-8556 Mobile and WhatsApp
Email:

dk@atlcp.com


大衛庫格爾曼
亞特蘭大資本夥伴有限責任公司
(866) 692-6847 免費電話-美國和加拿大
(404) 281-8556 手機和 WhatsApp
電子郵件:

dk@atlcp.com



声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
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