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FDA gives nod for Siemens Healthineers' Atellica CI Analyzer

por John R. Fischer, Senior Reporter | July 25, 2023
Siemens Healthineers' Atellica CI Analyzer
Siemens Healthineers has scored FDA clearance for the Atellica CI Analyzer for immunoassay and clinical chemistry testing, enabling it to provide U.S. labs facing a growing number of patient samples amidst a labor shortage and falling reimbursement rates with a solution that turns around results faster and facilitates access among different labs to the same clinical resources.

The analyzer has a planned menu of over 200 immunoassays for 20 diseases that a lab can choose from based on its patient population needs, and more than 50 key assays can produce results in under 14 minutes.

The solution is designed for labs with low to medium testing volumes but can be used by a lab of any size, and staff are better able to predict sample turnaround times through random access sampling, micro-volume aspiration, and automatic maintenance and quality control scheduling.

It also makes it possible for stand-alone labs and satellite labs in wider health networks to have the same reagents, consumables, and intelligent software as Siemens Healthineers’ flagship Atellica solution, which now has a 1.9-square-meter footprint for use in smaller clinical settings.

"Labs today need testing instrumentation and informatics that can easily keep pace with rapidly changing testing demands as they occur. This next-generation laboratory analyzer anticipates workflow bottlenecks, mitigates them proactively, and delivers insights based on data that help laboratory staff do their job more effectively and efficiently,” said Sharon Bracken, head of Diagnostics for Siemens Healthineers.

In the Atellica CI Analyzer, chemistry and immunoassay engines run independently to avoid compromising throughput if one of the two stops. Its different capabilities leverage downtime, create more space in the lab, and allocate staffing numbers per analyzer.

One of its features, the Atellica Laboratory Evaluation Suite, makes documentation reporting for inspections easier by helping labs meet accreditation guidelines without having to install new software. This saves on costs and allows staff to focus on other critical lab operations.

It also has user authentication, role-based authorizations, and audit trails to enhance security.

Siemens Healthineers installed the first U.S.-based Atellica system in 2018, offering labs a modular design for growing patient testing capacity and operating at quicker speeds.

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