Hemostasis
What we do
We develop, manufacture and distribute the highest quality, and most innovative systems, reagents and data management solutions for Hemostasis diagnostics. Our solutions help hospitals, hospital networks and commercial laboratories ensure quality results and enhance efficiency.
How we power patient care
As the world leader in Hemostasis, our portfolio of Diagnostic Management solutions powers the care clinicians provide to patients with bleeding and thrombotic disorders. Accurate, reliable results, received quickly, help inform key patient management decisions clinicians make every day.
Hemostasis in 2023
Maintaining our leadership in Hemostasis Specialized Diagnostics for another year
2023 was another solid year for our highly innovative Hemostasis business line. Advancing our leadership position, we grew the installed base of our flagship systems, ACL TOP Family 50 Series and ACL AcuStar. Of particular note, our leading HemoCell Specialized Lab Automation workcells achieved a significant uptick in installations, optimizing Hemostasis testing workflow around the world.
We are particularly proud of our newest testing systems, the ACL TOP Family 70 Series, which received 501(k) clearance from the US Food and Drug Administration (FDA) and Notification of Change from the In Vitro Diagnostic Medical Devices Regulation (IVDR) in 2023. Truly standardized, the ACL TOP Family 70 Series—which includes the ACL 970 CL, adding chemiluminescent technology for expanded testing breadth—is uniquely positioned as the most advanced Integrated Hemostasis Diagnostic Management Solution for hospitals and hospital networks. We look forward to commercializing these innovative systems throughout the world.
Our broad portfolio of clinically impactful assays was also expanded in 2023, with the extension of claims for the HemosIL Liquid Anti-Xa test kit in the United States to include measurement of rivaroxaban, when used in conjunction with HemosIL Rivaroxaban Calibrators and Controls. Rivaroxaban is a direct oral anticoagulant used to reduce the risk of stroke and blood clots. Additionally, we received 510(k) clearance from the US FDA, as well as IVDR clearance, for Chromogenic Factor IX.
In Digital Solutions, HemoHub Intelligent Data Manager and AccuTrak 2.0, a key tool for laboratory quality control management, reached significant customer adoption milestones. Cloud-based ProDx 2.0 Remote Support Suite entered controlled distribution in the United States, to remotely monitor instrument and data management performance at customer sites, maximizing instrument operation.
As the leader in Hemostasis Specialized Diagnostics, we continued to earn this honor in 2023, by driving innovation across our systems, reagents, and digital solutions, to enhance efficiency in laboratories and to power patient care.
Giovanni Russi
Chief Operating Officer
Hemostasis and Acute Care Diagnostics
2023 business highlights
Our products
Powering Patient Care
ACL TOP® Family 50 Series
Hemostasis Testing Systems
A breakthrough in Hemostasis testing, ACL TOP Family 50 Series systems offer the most advanced automation and quality management, for routine to specialty assays. Designed for mid- to high-volume clinical laboratories, including those with Lab Automation tracks, all models are standardized for superior performance across the entire testing process. Automated pre-analytical sample-integrity checks, advanced quality and accreditation support and enhanced system security assure quality results and lab efficiency.
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HemoCell® Specialized Automation Workcell
The world’s first lab automation solution designed specifically for Hemostasis testing, HemoCell Specialized Lab Automation is a customizable and fully automated workcell. Integrating the best-in-class ACL TOP 750 LAS testing systems, HemoHub Intelligent Data Manager, HemosIL reagents and a Laboratory Automation track, HemoCell optimizes testing to achieve greater efficiencies, enhanced quality and reduced costs.
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HemoHub™ Intelligent Data Manager
Unmatched operational performance and clinical decision support, all from a single workstation. HemoHub Intelligent Data Manager enhances the efficiency of the entire Hemostasis testing operation, improving workflow and decision-making, and ultimately, patient care.
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ACL AcuStar®
Hemostasis Testing System
The first specialty testing analyzer to offer full automation of highly sensitive immunoassays, the ACL AcuStar delivers unprecedented accuracy and efficiency. Advanced assay technology, complemented with end-to-end automation, enhances simplicity and throughput, with uncompromised results. Complete specialty testing in as little as 25 minutes, with no special training required.
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