FDA clears Abbott’s Alinity diagnostic analyzers

Abbott (NYSE:ABT) said today it won FDA 510(k) clearance for its Alinity instruments for clinical chemistry and immunoassay diagnostics.

The newly launched ci-series of Alinity devices includes improvements such as smaller footprints, improved workflow capabilities and reduced wait times and simplified designs for error proofing and enhanced usability, the company said.

“Healthcare systems across the United States are under pressure to deliver better care for patients. Labs and healthcare systems are looking for complete solutions that help them operate more efficiently while contributing to better clinical decision making and helping improve patient outcomes. FDA clearance is a key first step in bringing this important innovation to our U.S. customers as we work to gain approval for the full Alinity portfolio of instruments and assays,” Abbott diagnostic products exec VP Brian Blaser said in a prepared statement.

Abbott said its Alinity system includes the Alinity c clinical chemistry system and the Alinity i immunoassay system, both of which can operate individually or work together as an integrated Alinity ci-series unit.

“Alinity ci was designed using a different approach. We went beyond traditional market research and spent countless hours with our customers, listening to their challenges and observing how they work. With customer insights as our roadmap, the Alinity ci is engineered to simplify diagnostic testing while ensuring speed, accuracy and performance,” immunoassay and clinical chemistry R&D VP John Frels said in prepared remarks.

The company said that in addition to the instrument clearance, it has also obtained clearance for several tests on the system with a “comprehensive menu of tests expected to be available within a year of launch,” according to a press release.

Yesterday, Abbott said it won CE Mark approval in the European Union for its next-generation drug-eluting stent, the Xience Sierra.

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