/PRNewswire/ -- Scopio Labs, a trailblazer in Full-Field Digital Cell Morphology, today announced another significant milestone: its fourth U.S. Food and Drug Administration (FDA) clearance (K243144). This latest clearance introduces powerful new Decision Support System (DSS) features to its X100 and X100HT platforms and Peripheral Blood Smear (PBS) Application, further transforming the way laboratories analyze red blood cell (RBC) morphology and identify platelet clumps in peripheral blood smears..

/PRNewswire/ -- 全视野数字细胞形态学领域的先驱Scopio Labs今天宣布了另一个重要的里程碑：其获得了第四项美国食品药品监督管理局（FDA）的批准（K243144）。此次最新批准为其X100和X100HT平台以及外周血涂片（PBS）应用引入了强大的新型决策支持系统（DSS）功能，进一步改变了实验室分析红细胞（RBC）形态和识别外周血涂片中血小板聚集的方式。

This important clearance builds on Scopio Labs' proven track record of innovation, enhancing its already FDA-cleared Full-Field Peripheral Blood Smear (PBS) Application. The upgraded solution is designed to empower qualified hematology lab professionals and enhance their conventional analysis methods by examining thousands of cells and providing intelligent, AI-driven analysis and grading for 23 distinct RBC morphology parameters and for the presence of platelet clumps, across the clinically relevant areas of the sample, from the monolayer to the feathered edge.

这一重要许可建立在Scopio Labs经过验证的创新记录之上，进一步提升了其已获FDA批准的全视野外周血涂片（PBS）应用程序。升级后的解决方案旨在赋能合格的血液学实验室专业人员，增强其传统分析方法，通过检查成千上万个细胞，并提供智能化、由AI驱动的分析和分级，涵盖23个不同的红细胞形态参数以及血小板聚集的存在情况，覆盖样本从单层到羽状边缘的临床相关区域。

This leap forward supports greater consistency and efficiency in analysis, while crucially maintaining the essential oversight of human experts in the diagnostic process..

这一飞跃支持了分析过程中更大的一致性和效率，同时至关重要的是保持了人类专家在诊断过程中的必要监督。

'These enhancements bring added consistency and efficiency to digital morphology review,' said

“这些增强功能为数字形态学检查带来了更高的一致性和效率，”

Itai Hayut

伊泰·哈尤特

, CEO at Scopio Labs. 'With this FDA clearance, we're proud to extend access to our decision support capabilities to US-based hematology labs, supporting clinical teams with solutions that align seamlessly with established workflows'

Scopio Labs首席执行官表示：“通过此次FDA的批准，我们很自豪能够将我们的决策支持功能扩展到美国的血液学实验室，为临床团队提供与现有工作流程无缝对接的解决方案。”

The Scopio Full-Field PBS Application, integrated with the X100 and X100HT platforms, continues to deliver comprehensive digital imaging, detecting, displaying and classifying the different blood cells. It assists hematology lab professionals in critical tasks such as WBC differentials, RBC morphology evaluation, and platelet estimates.

Scopio全视野PBS应用与X100和X100HT平台集成，持续提供全面的数字成像、检测、显示和分类各种血细胞的功能。它协助血液学实验室专业人员完成关键任务，如白细胞分类、红细胞形态评估和血小板计数估算。

This new clearance ensures that while AI provides valuable insights, the final decision remains confidently in the hands of the trained professional..

这一新的审批确保了虽然人工智能提供了有价值的见解，但最终的决定仍然自信地掌握在训练有素的专业人士手中。

Scopio Labs is dedicated to driving the digital transformation of hematology labs, providing cutting-edge solutions that elevate diagnostic precision, streamline lab operations, and ultimately enhance patient care globally.

Scopio Labs致力于推动血液学实验室的数字化转型，提供尖端解决方案，提升诊断精度、简化实验室操作，并最终改善全球患者护理。

About Scopio Labs:

关于Scopio Labs：

Scopio Labs is the developer of full-field digital imaging for hematology diagnostics. By supporting laboratory scientists and clinicians with unprecedented scale and depth in digital cell morphology, the company's platforms enable timely detection of blood-related medical conditions, expediting patients' access to life-saving treatments.

Scopio Labs是血液学诊断全视野数字成像的开发者。通过在数字细胞形态学方面为实验室科学家和临床医生提供前所未有的规模和深度，该公司的平台能够及时检测与血液相关的医疗状况，加快患者获得挽救生命的治疗。

Scopio solves cell morphology's age-old trade-off between resolution and field of view. Its high-resolution imaging and embedded AI combine for more efficient remote workflow, contributing to better diagnostics across the continuum of care. Scopio Labs' Full-Field Peripheral Blood Smear Application and Full-Field Bone Marrow Aspirate Application are FDA-cleared and CE-marked for use with the Scopio X100 and Scopio X100HT platforms and cleared for sale in additional regions.

Scopio解决了细胞形态学中分辨率和视野之间长期存在的权衡问题。其高分辨率成像和嵌入式人工智能相结合，实现了更高效的远程工作流程，有助于在护理全流程中提供更好的诊断。Scopio Labs的全场外周血涂片应用和全场骨髓抽吸应用已获得FDA批准和CE认证，可与Scopio X100和Scopio X100HT平台配合使用，并已在其他地区获准销售。

The Full-Field Bone Marrow Aspirate Application is not commercially available in the US for in vitro diagnostic procedures. To learn more, visit .

全视野骨髓抽吸应用在美国尚未商业化用于体外诊断程序。欲了解更多信息，请访问 。