AI Optics获得FDA批准，增加患者视网膜筛查的机会-动脉网

AI Optics Receives FDA Clearance, Increasing Patient Access to Retinal Screening

CISION 等信源发布 2025-01-28 21:10

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NEW YORK

纽约

Jan. 28, 2025

2025年1月28日

/PRNewswire/ --

/美通社/ --

AI Optics Inc.

AI光学公司。

, an AI-focused medical device company announced today that it has received FDA 510(k) clearance for its

，一家专注于人工智能的医疗器械公司今天宣布，它已获得FDA 510（k）的许可

Sentinel Camera

哨兵摄像机

. This handheld retinal imaging system captures high-quality images of the human eye, helping to address critical gaps in retinal disease screening through a portable and accessible solution.

这种手持式视网膜成像系统可以捕获高质量的人眼图像，通过便携式和可访问的解决方案帮助解决视网膜疾病筛查中的关键差距。

继续阅读

Revolutionizing retinal screening: AI Optics' FDA-cleared Sentinel Camera brings retinal screening anywhere.

革命性的视网膜筛查：AI Optics的FDA认证前哨摄像头将视网膜筛查带到任何地方。

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AI Optics FDA Cleared Sentinel Camera

AI Optics FDA认可的哨兵摄像头

Over one billion people are at risk for retinal diseases, yet access to screening remains limited due to specialist shortages, cost, and convenience barriers. The Sentinel Camera helps tackle these challenges by enabling point-of-care retinal imaging, eliminating the need for some patients to visit an eye specialist's office.

超过10亿人面临视网膜疾病的风险，但由于专家短缺，成本和便利障碍，筛查的机会仍然有限。哨兵摄像头通过实现即时视网膜成像来帮助应对这些挑战，从而消除了一些患者访问眼科专家办公室的需要。

It is intentionally designed to be easy to use and support non-dilated imaging, while being both affordable and portable. The design was also developed to meet the needs of general healthcare providers, including primary care, optometry, retail health clinics, and home health settings, ensuring accessibility and practicality in these environments. .

它有意设计为易于使用并支持非扩张成像，同时价格合理且便携。该设计还旨在满足普通医疗保健提供者的需求，包括初级保健，验光，零售保健诊所和家庭保健环境，确保在这些环境中的可访问性和实用性。。

Collaborating with NYU Langone Health

与纽约大学Langone Health合作

AI Optics is strategically collaborating with NYU Langone Health to advance the accessibility and implementation of retinal screening technology. This partnership aligns with AI Optics' mission to address the global challenge of preventable blindness by providing innovative tools that meet the needs of healthcare providers and patients.

AI Optics正在与纽约大学朗根健康中心进行战略性合作，以推进视网膜筛查技术的可及性和实施。这种合作关系符合AI Optics的使命，即通过提供满足医疗保健提供者和患者需求的创新工具来应对可预防失明的全球挑战。

The FDA clearance of the Sentinel Camera marks a pivotal step in this journey, enabling the integration of high-quality, portable imaging into diverse healthcare environments..

FDA对哨兵相机的批准标志着这一旅程的关键一步，使高质量的便携式成像能够集成到不同的医疗环境中。。

'Early detection of retinal diseases is critical to preserving vision. At NYU Langone Health, we are dedicated to advancing innovative approaches that enhance access to retinal screening while continually improving patient outcomes' said

“早期发现视网膜疾病对于保持视力至关重要。在纽约大学朗格尼健康中心，我们致力于推进创新方法，以增强视网膜筛查的机会，同时不断改善患者的预后

Kathryn Colby

凯瑟琳科尔比

, MD, PhD, the Elisabeth J. Cohen, MD, Professor of Ophthalmology and Chair of the Department of Ophthalmology at the NYU Grossman School of Medicine.

，医学博士，医学博士ElisabethJ.Cohen，医学博士，纽约大学格罗斯曼医学院眼科教授兼眼科系主任。

A Foundation for Future Innovation

未来创新的基础

AI Optics is also developing AI-based retinal screening software for future integration, with a plan to provide a comprehensive end-to-end solution for detecting retinal diseases like diabetic retinopathy, glaucoma, and macular degeneration.

AI Optics还正在开发基于AI的视网膜筛查软件，以备将来集成，计划为检测糖尿病视网膜病变，青光眼和黄斑变性等视网膜疾病提供全面的端到端解决方案。

'Our vision with the Sentinel Camera is to eliminate barriers to retinal screening and ensure that every patient who needs screening has access,' said

“我们使用哨兵摄像头的愿景是消除视网膜筛查的障碍，确保每个需要筛查的患者都有机会，”他说

Luke Moretti

卢克·莫雷蒂

, Co-Founder and CEO of AI Optics. 'This FDA clearance not only validates our significant progress to breaking down screening barriers but also sets the stage for our future AI-powered screening solutions, which will integrate seamlessly with the Sentinel Camera to deliver unparalleled accessibility and efficiency in retinal disease detection.'.

，AI Optics的联合创始人兼首席执行官FDA的批准不仅验证了我们在打破筛查障碍方面取得的重大进展，而且为我们未来的人工智能筛查解决方案奠定了基础，该解决方案将与前哨摄像头无缝集成，在视网膜疾病检测中提供无与伦比的可及性和效率。”。

The Sentinel Camera supports DICOM-compliant image formats, allowing integration with Electronic Health Record (EHR) systems to streamline care coordination, billing, and data sharing. When combined with AI Optics' upcoming AI capabilities, the system will further enhance point-of-care screening workflows and diagnostic efficiency, significantly improving .

Sentinel摄像头支持符合DICOM标准的图像格式，允许与电子健康记录（EHR）系统集成，以简化护理协调、计费和数据共享。当与AI Optics即将推出的AI功能相结合时，该系统将进一步增强护理点筛查工作流程和诊断效率，从而显着提高。

early detection and outcomes for patients.

患者的早期发现和结果。

The Sentinel Camera's development was driven by the urgent need to address the global burden of preventable vision loss. By creating tools that bring screening directly to point-of-care settings, AI Optics is empowering healthcare providers to deliver early and accurate retinal disease diagnoses to patients across diverse settings, improving accessibility and outcomes for all..

哨兵相机的发展是由于迫切需要解决全球可预防视力丧失的负担。通过创建将筛查直接带到即时护理环境的工具，AI Optics使医疗保健提供者能够在不同环境中为患者提供早期准确的视网膜疾病诊断，从而改善所有人的可及性和结果。。

Disclosures:

披露：

NYU Langone Health holds equity in AI Optics. These interests are being disclosed and managed in accordance with NYU Langone Health policies.

纽约大学朗根健康持有AI光学的股权。这些利益正在根据纽约大学朗格尼分校的健康政策进行披露和管理。

For more information about the Sentinel Camera and AI Optics' innovative solutions, visit

有关Sentinel相机和AI Optics创新解决方案的更多信息，请访问

www.aioptics.ai

Contact for media enquiries

媒体咨询联系人

Luke Moretti

卢克·莫雷蒂