Sysmex America's CN-6000™ Analyzer Receives FDA Approval

Author: Evelyn Baker Updated: 06-25-2025 10:11 AM

Sysmex America Gains FDA Clearance for CN-6000™ Analyzer

Sysmex America, Inc., a prominent name in diagnostic solutions including hematology and hemostasis, has received FDA clearance for its CN-6000™ Automated Blood Coagulation Analyzer. This new development signifies a major stride in laboratory technology, particularly in the field of blood coagulation testing, by ensuring accuracy and efficiency in diagnosing blood disorders.

Enhanced Testing Capabilities

The CN-6000™ analyzer not only streamlines testing processes but also supports five crucial hemostasis tests. These tests include:

Prothrombin Time (PT) and PT INR with Dade® Innovin®
Activated Partial Thromboplastin Time (APTT) with Dade® Actin® FSL
Fibrinogen (Fbg) with Dade® Thrombin Reagent
Antithrombin (AT) with INNOVANCE® Antithrombin
D-dimer with INNOVANCE® D-Dimer

With the capacity to deliver high-volume testing in a compact design, the CN-6000™ is tailored to meet the demands of busy laboratories.

Commitment to Innovation and Quality

Dan Zortman, CEO of Sysmex America, expressed confidence in the technology behind the CN-6000™, stating, "Sysmex's hemostasis solutions combine advanced technology and trusted reagents, ensuring laboratories can produce reliable results for patients with bleeding or clotting disorders." This statement highlights Sysmex's commitment to providing tools that healthcare professionals can depend on.

Addressing Laboratory Demands

To accommodate labs handling significant workloads, Sysmex offers an optional sampler, which significantly increases sample loading capabilities. This flexibility ensures that even those with high demands can maintain workflow efficiency without compromising on accuracy.

Future Developments and Vision

Sysmex remains dedicated to expanding its range of blood coagulation solutions. The company is actively working towards gaining market authorization for the CN-3000 and its associated reagents, which are designed with the same ethos of quality and precision as the CN-6000™.

About Sysmex America

As the regional division of Sysmex Corporation based in Kobe, Japan, Sysmex America is recognized for revolutionizing healthcare with innovative diagnostic products. Their advanced systems in hematology, hemostasis, urinalysis, and flow cytometry not only aim to improve operational performance in clinical laboratories but also enhance the decision-making process for healthcare providers, ensuring patient care is greatly informed. Sysmex’s contributions to healthcare have earned accolades, with Forbes magazine highlighting it as one of the most innovative companies in the healthcare equipment sector.

Frequently Asked Questions

What is the CN-6000™ Automated Blood Coagulation Analyzer?

The CN-6000™ is an FDA-cleared automated analyzer designed to enhance the accuracy and efficiency of blood coagulation testing.

What types of tests can the CN-6000™ perform?

It supports crucial hemostasis tests including PT, INR, APTT, fibrinogen, antithrombin, and D-dimer assessments.

How does Sysmex America's CN-6000™ improve laboratory efficiency?

The CN-6000™ offers high throughput and fully automated testing while maintaining a space-saving design, perfect for busy environments.

What is Sysmex America’s vision for the future?

Sysmex aims to continuously innovate in the diagnostic field, planning to launch more advanced products, including the CN-3000™ analyzer.

Who can benefit from Sysmex's diagnostic solutions?

Healthcare providers and laboratories that require reliable and efficient diagnostic tools for blood-related disorders can benefit significantly from Sysmex's offerings.

About The Author

Greetings, I'm 32-year-old author and financial specialist Evelyn Baker. My introduction into the financial industry started with an economics degree and continued with a wealth of experience in wealth management and financial consulting. My great passion over the years has been assisting people and companies in making wise, well-informed decisions to reach their financial objectives.

My goal with writing is to simplify difficult financial ideas into understandable, doable guidance. My goal in writing many books and articles is to make personal finance understandable to everyone, irrespective of their experience or background. I want to give readers the information they need to take charge of their financial futures, from investing and retirement planning to budgeting and saving.

Along with my writing, I lead webinars and workshops where I provide doable advice and methods for achieving financial success. To reach a larger audience, I also frequently contribute to financial blogs and publications. My method is always to offer doable, real-world guidance that can actually improve people's lives.

Aside from my job, I like to cook, travel, and experience other cultures. I work hard to apply my belief in the value of a balanced life to my financial counsel. My goal in working is to encourage and enable people to succeed financially so they may lead the best lives possible.

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