Clinical History
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1978
CIM-101A
Shimadzu's first clinical ion meter that automatically measures Na, K, and Cl ions in the blood.
Clinical History
1979
CL-12
Shimadzu's first clinical chemistry analyzer.
1989
CL-7200/7300
Shimadzu launched a fully automated clinical chemistry analyzer, the CL-7300, in Japan, utilizing a dual single multi-method with a turntable design. It can perform up to 1200 tests per hour and won the Good Design Award in 1990 (No. 90J0732).
1993
CIM-300
Shimadzu launched a clinical ion meter in Japan that automatically measures Na, K, and Cl ions in blood, integrating this technology into its clinical chemistry analyzer. It received the Good Design Award in 1993 (No. 93J0585).
1993 - present
Automated blood coagulation analyzer
Shimadzu developed its first automated blood coagulation analyzer, the CR-700, in 1993. This line has evolved through the CR-800 (1999), Copapresta 2000 (2007), CP-3000 (2013), and CP-3000α (2025). The CR-700 featured random access and probe pickup methods, while the CR-800 introduced a compact design and innovations.
2017
CLAM-2000 CL
Shimadzu has launched the CLAM-2000 CL, a fully automated preparation module for LC-MS. This device automates the entire process from preparing urine, blood, and other biological samples to measurement via liquid chromatography mass spectrometry (LC-MS). As the world's first fully automated LCMS pretreatment device using proven blood coagulation analysis technology, it allows for complete automation of analysis by simply setting the blood collection tube.
2018
DOSIMMUNE™
Shimadzu Chemistry & Diagnostics, a Shimadzu Grop Company, has released DOSIMMUNE™, a reagent kit to quantify immunosuppressant drugs (Cyclosporin A, Everolimus, Sirolimus, Tacrolimus) in whole blood using LC/MS/MS. This reagent kit, CE marked, is ready-to-use with all the components and accessories required to monitor immunosuppressants in patient whole blood sample.
2020
AutoAmp
Shimadzu Corporation has released the AutoAmp Genetic Analyzer (“AutoAmp”) for sale in Japan, enabling clinics to perform fully-automatic PCR testing. With the AutoAmp, classified as a Class I medical device, PCR testing involves simply setting the biological samples, dispensing tips, reagent vials, and reaction vessels in place. This instrument can also be used to detect the novel coronavirus (SARS-CoV-2) using the Ampdirect™ 2019-nCoV Detection Kit of in-vitro diagnostic reagents offered by Shimadzu.
CLAM-2030 CL
After launching the CLAM-2000 CL in 2017, Shimadzu has released the CLAM-2030 CL, a fully automated sample preparation module for LCMS. The CLAM-2030 improves the stability of internal standards and precipitation reagents, and it features upgraded operational software. These enhancements help stabilize data acquisition, reduce running costs, and improve operational efficiency.
Amyloid MS CL AXIMA
Shimadzu Corporation has obtained medical device approval in Japan for the 'Blood Amyloid Peptide Measurement System (Amyloid MS CL), which measures candidate substances related to the causes of Alzheimer's disease. The 'Amyloid MS CL' measures amyloid peptides in the blood (the main component of amyloid plaques, which are characteristic of Alzheimer's disease) and presents biomarker values related to amyloid β (a protein believed to be a cause of the disease).
2022
LC-40 CL and LCMS-8045/8050/8060/8060NX CL (IVDR class A)
Shimadzu has launched IVDR Class A devices for HPLC (LC-40 CL) and LC-MS/MS (LCMS-8045/8050/8060/8060NX CL).
2023
CLAM-2040 CL (IVDR class A)
After releasing CLAM-2030 in 2020, Shimadzu released the CLAM-2040 CL. The CLAM-2040 CL is a flexible and seamless device that can be paired with an IVDR class A compliant LC-MS/MS, depending on the application. It connects to the Laboratory Information System (LIS), enhancing testing capabilities and workflow efficiency. When combined with commercially available IVD kits, it helps users meet the requirements of Article 5(5) of IVDR, making it popular in therapeutic drug monitoring (TDM), steroids, vitamin D, and toxicology.
Clinical Stories
Throughout its 150-year history, Shimadzu has gathered numerous stories that exemplify its role in the advancement of analytical technology. Each narrative reflects the contributions of individuals and the evolution of innovations across various fields. Below, we present some of these stories that highlight key milestones in our journey and the impact they have had.
Faster throughput. Together.
To face increasing demands on their time and resources, chemical laboratories need easier-to-handle solutions with faster turnaround times, lower costs per sample and full compliance with ever-stricter regulatory standards. Recent work by Alsachim using Shimadzu equipment and software has now led to an optimized high-throughput analytical solution that delivers same-day results for therapeutic drug monitoring of immunosuppressants. The solution combines liquid chromatography and tandem mass spectrometry (LC-MS/MS) with automated sample preparation and a dedicated reagent kit.
Precision beats estimation – GFR measurement by iohexol plasma clearance
The glomerular filtration rate (GFR) plays a vital role in monitoring the kidney function. Even though kidney diseases rank as the 10th leading global cause of death, resulting in 1.3 million deaths annually (2019), the vast majority of GFR determinations are based on estimation (eGFR). These estimations lack clinical accuracy, which can lead to uncertainty in clinical decision-making, especially for critical patient cases. According to the international Kidney Disease: Improving Global Outcomes (KDIGO) organization, reliable and accurate results can only be achieved by direct measurement of the GFR (mGFR) using exogenous markers such as iohexol.
MS detection of Alzheimer’s blood-based biomarkers
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Amyloid β (Aβ) accumulation in the brain is considered as the earliest sign of Alzheimer’s disease (AD) pathology. Recently developed disease-modifying therapies (DMTs) target patients with early-stage AD, hence blood-based biomarkers are needed for a detection of Aβ accumulation. We combined immunoprecipitation (IP) with mass spectrometry (MS) to develop an IP-MS technique that resulted in the first successful detection of plasma Aβ by MS. This technique revealed a high concordance between a composite biomarker of two plasma Aβ ratios and amyloid PET status. As advances are made in DMTs, blood-based biomarkers will become increasingly valuable due to their key role for screening patients, monitoring drug effects and diagnosis.
Clinical Events
Are you interested in our Clinical products? You can explore them up close at various upcoming events. Our experts will be available to answer any questions you may have. We look forward to seeing you there!
EACPT 2025
- When? 28 June - 1 July 2025
- Where? Helsinki, Finland
MSACL 2025
- When? 21 - 25 September 2025
- Where? Montreal, Canada
IATDMCT 2025
- When? 21 - 24 September 2025
- Where? Singapore
Discover our collection of clinical solutions
RECIPE ClinMass® TDM platform with full automation
Shimadzu has been paving the way for automated LC-MS/MS (CLAM series) since 2015 and is nowadays offering a step further to the clinical laboratory's community. Discover the IVD kits from the RECIPE ClinMass® TDM platform now available to be used on Shimadzu automated IVDR class A solutions for LC-MS/MS!
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LC/LCMS IVD
Navigating IVDR Article 5(5) requirements with RUO systems can be overwhelming—but there’s a smarter way. Shimadzu’s IVDR Class A certified HPLC, LC-MS/MS, and the fully automated CLAM-2040 CL simplify compliance and reduce workload. Flexible, customizable, and seamlessly integrable with LIS/LAS systems, these devices offer a powerful diagnostic workflow.
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LCMS TQ & HRMS
From high-throughput labs to compact workspaces, Shimadzu’s LC-MS systems deliver unmatched performance, sensitivity, and ease of use. Whether you need SQ, TQ, or Q-TOF technologies, our instruments are designed to meet diverse analytical needs with precision and reliability. With smart automation and intuitive software, even complex workflows become effortless.
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Diagnostic reagent kits for LCMS
Shimadzu’s DOSIMMUNE™ is a CE-marked, ready-to-use LC-MS/MS reagent kit for accurate quantification of immunosuppressant drugs in whole blood. Complete with calibrators, controls, internal standards, and consumables, it's a true turnkey solution designed for lab efficiency and standardization. Backed by full documentation and manufacturer support, DOSIMMUNE™ streamlines your workflow and ensures consistent results.
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Middleware Solution Gateway
LabGateway is Shimadzu’s powerful middleware solution designed to automate, centralize, and streamline data flow between your lab instruments and LIS. With full traceability, customizable modules, and smart automation, it enhances efficiency, reduces manual errors, and supports accreditation efforts. Whether managing clinical data, reagents, or user profiles, LabGateway delivers secure, scalable integration for modern laboratories.
Interested in our clinical solutions?