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Medical Devices / Submissions and Approvals

Singulex Gains CE Mark for Sgx Clarity System

April 4, 2017

California–based Singulex have received a CE mark for its Sgx Clarity system, an automated, in vitro diagnostics (IVD) platform powered by single molecule counting technology.

Singulex will submit data for regulatory clearance of the Sgx Clarity system in the United States, anticipating FDA clearance in 2018.

Singulex is also developing a point-of-care platform for its single molecule counting technology. — Cynthia Jessup

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