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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 报告在 DeepView 系统验证中进行了超过 511 天的专家参与,以便提交给 FDA。
Quiver Quantitative ·  12/12 08:13

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

Spectral AI报告显示,医生参与DeepView培训显著增强了其基于人工智能的烧伤愈合预测系统。

Quiver AI Summary

Quiver AI 概要

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是一家开发用于预测烧伤愈合的人工智能驱动的DeepView系统的公司,宣布全国烧伤护理领导者贡献了超过511个面对面的培训日,以训练和验证该系统以提交FDA,同时还有额外的250个用于概念验证研究。参与者包括美国烧伤协会的杰出成员和领先的医疗期刊,突显了增强系统可信度和有效性的显著合作努力。DeepView技术结合了先进成像和人工智能,评估创伤愈合潜力,2018年获得FDA突破性医疗器械认证,并在今年早些时候获得英国CA标志。该系统旨在通过提供客观评估和降低医疗成本,提高患者在创伤护理中的治疗效果。

Potential Positives

潜在的积极因素

  • 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.
  • 来自国家烧伤护理领导者的显著参与,超过511个面对面的培训日致力于DeepView系统的培训和验证,表明对该技术的强大专业支持和认可。
  • 此次合作包括杰出专业人士,如三位现任或前任美国烧伤协会会长,增强了培训过程的可信度和可靠性。
  • DeepView此前获得了美国FDA的突破性医疗器械认证,突显了其在医疗诊断和患者护理中的潜在影响。
  • 获得烧伤适应症的英国合规评估(UKCA)标志,使DeepView在国际市场中的潜在市场和接受度扩大。

Potential Negatives

潜在负面因素

  • 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.
  • 新闻稿强调了国家领导人在烧伤护理方面的广泛参与,这可能引发对Spectral AI内部专业知识充足性的担忧。
  • 提到的“前瞻性声明”及相关风险可能表明公司未来表现的不稳定或不确定,从而可能抑制投资者的兴趣。
  • 重点关注合作和外部验证,这可能意味着公司的技术尚未独立证明或具备商业可行性。

FAQ

常见问题

What is the DeepView System developed by Spectral AI?

Spectral AI开发的DeepView系统是什么?

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

DeepView系统是一个基于人工智能的伤口诊断平台,利用多光谱成像和先进算法预测烧伤愈合潜力。

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

有多少天的医生参与用于DeepView培训?

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

超过511个医生参与的面对面日用于DeepView系统的培训和验证研究。

What recognition did DeepView receive from the FDA?

DeepView获得了FDA的什么认可?

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

DeepView于2018年获得美国FDA的突破性设备认定,标志着其在医疗诊断中的重要性。

Who contributed to the validation studies for DeepView?

谁为DeepView的验证研究作出了贡献?

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

全国烧伤护理的领导者,包括美国烧伤协会的会长和董事会成员,为验证研究作出了贡献。

What are the initial applications of DeepView technology?

DeepView技术的初始应用是什么?

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

DeepView技术的初始应用主要集中在伤口护理,尤其是针对烧伤和糖尿病足溃疡患者。

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.

免责声明:这是由GlobeNewswire分发的新闻稿的人工智能生成摘要。用于总结这份稿件的模型可能会出错。请在这里查看完整发布。


$MDAI Hedge Fund Activity

$MDAI对冲基金活动

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

我们看到12个机构投资者在最近一个季度中增加了$MDAI股票的持股,10个减少了他们的持仓。

Here are some of the largest recent moves:

以下是最近的一些重大变动:

  • 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年第三季度增加了110,727股(+3261.5%)的持股。
  • AVANTAX PLANNING PARTNERS, INC.在2024年第三季度增加了95,493股(+148.4%)的持股。
  • 先锋集团在2024年第三季度增加了43,872股(+71.3%)的持股。
  • MURCHINSON LTD.在2024年第二季度减少了40,000股(-100.0%)的持股。
  • 瑞银在2024年第三季度增加了39,105股(+3910500.0%)的持股。
  • GEODE CAPITAL MANAGEMENT, LLC在2024年第三季度新增29,527股(+43.9%)
  • MYDA ADVISORS LLC在2024年第二季度减持20,000股(-100.0%)

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

要跟踪对冲基金的股票投资组合,请查看Quiver Quantitative的机构持有情况仪表。

Full Release

完整发布



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.


达拉斯,2024年12月12日(环球新闻通讯社)——Spectral AI(纳斯达克:MDAI)("Spectral AI"或"公司"),人工智能驱动的DeepView系统的开发者,



该系统于2018年获得美国FDA的突破性设备认定,利用多光谱成像和算法预测烧伤愈合潜力,今天宣布,国家烧伤护理领导者已投入估计超过511个面对面医生参与的日子用于DeepView系统在美国食品药品监督管理局(FDA)提交的培训和验证研究。这并不包括这些专家在概念验证研究中投入的超过估计250天的额外时间。



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.


这一非凡的合作涵盖了来自全国的医生,这些医生在烧伤护理领域是全国领军人物。他们包括三位现任或前任会长,以及十位美国烧伤协会的董事会成员和前董事会成员,以及两位领先医疗烧伤期刊的主编。如此杰出的专业人士参与的程度,代表了他们与Spectral AI团队合作开发人工智能算法的前所未有的时间和专业技术投资。



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的专利DeepView



技术是一个由人工智能驱动的创伤诊断平台,结合了爱文思控股算法和医疗成像,能够预测创伤愈合潜力,该平台已获得FDA的突破性认证。该平台依赖于一个专门的数据集,能够识别关键模式并提供引人注目的临床洞察。这一与世界级烧伤专家团队的独特合作增强了数据集的可信度和可靠性,并强调了研究的突破性特性。



"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."


“这种合作水平代表了国家烧伤护理领域领导者们前所未有的时间和精力投入,”研究的首席研究员Jeffrey Carter万.D.博士说。“我们对Michael DiMaio博士的领导以及这一杰出临床团队的参与深表感谢。”



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董事会主席迈克尔·迪马约博士补充说:"我对我们的Spectral AI团队感到非常自豪,尤其是我们能够在DeepView的培训和验证研究中包含一些我国最受尊敬的烧伤专家。这些专家使算法能够由经验丰富的顶级临床医生进行训练,这一联合努力反映了我们确保DeepView的决心。



系统成为烧伤护理的黄金标准工具。"



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.


DeepView



在2018年获得了来自美国FDA的突破性医疗器械认证,这一显著的支持。此外,今年早些时候获得英国合格标志(UKCA)用于烧伤适应症,使DeepView的潜力更有可能成为医疗诊断领域的变革者。



作为医疗诊断中的潜在游戏规则改变者。




About Spectral AI



本新闻稿中的某些声明是“前瞻性声明”,在美国《私人证券诉讼改革法》第21E条的“安全港”规定下进行。这些前瞻性声明涉及到公司的策略、计划、目标、倡议和财务展望。在本新闻稿中使用的“估计”、“预计”、“预测”、“计划”、“打算”、“相信”、“寻求”、“可能”、“将”、“应该”、“未来”、“建议”及其变体或类似表达(或这些单词或表达的否定版本)旨在识别前瞻性声明。



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.是一家位于达拉斯的预测人工智能公司,专注于医疗诊断,以便更快速和准确地为伤口护理作出治疗决策,最初的应用涉及烧伤和糖尿病足溃疡患者。该公司正在努力通过“看见未知”来革新伤口护理的管理。



与其DeepView系统。



DeepView是一个预测设备,能够在治疗或其他医疗干预之前,客观、即时地评估伤口的愈合潜力。通过算法驱动的结果及在未来超越当前护理标准的目标,DeepView预计将提供更快速、更准确的治疗洞察,从而改善患者的治疗效果,降低医疗成本。有关DeepView的更多信息,访问



.




Forward-Looking Statements



前瞻性声明



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.


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.



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.


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.



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.


投资者应仔细考虑上述因素以及公司在向美国证券交易委员会提交的文件中描述的其他风险和不确定性,包括注册声明和公司提交的其他文件。这些文件识别并处理其他重要风险和不确定性,这些风险和不确定性可能导致实际事件和结果实质性偏离前瞻性声明中包含的内容。除法律要求外,Spectral AI不承担更新任何前瞻性声明的义务。



For Media and Investor Relations, please contact:


如需媒体和投资者关系信息,请联系:



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

dk@atlcp.com


大卫·库格尔曼
亚特兰大资本合作伙伴有限公司
(866) 692-6847 免费电话 - 美国及加拿大
(404) 281-8556 手机和WhatsApp
电子邮件:

dk@atlcp.com



声明:本内容仅用作提供资讯及教育之目的,不构成对任何特定投资或投资策略的推荐或认可。 更多信息
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