FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Beckman Coulter Assay Wins CE Mark

Nov. 13, 2017

Beckman Coulter Diagnostics received a CE Mark for a new high-sensitivity troponin (hsTnI) assay that aids in diagnosing myocardial infarction in patients presenting with chest pain or other ischemic symptoms.

The assay will allow hospitals to develop fast-track protocols leading to early discharge for patients with suspected myocardial infarction, the company said.

The assay can be used with the Access 2, DxI and Beckman Coulter’s family of Access immunoassay systems.

View today's stories