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FDA Clears Polymedco POC Myocardial Infarction Test

NEW YORK — Polymedco on Wednesday said its PathFast Biomarker Analyzer for diagnosing myocardial infarction at the point of care has been 510(k)-cleared by the US Food and Drug Administration.

According to the Cortlandt Manor, New York-based company, the platform delivers results in 17 minutes, giving emergency departments and other acute care facilities the ability to make diagnostic and treatment decisions at the point of care more quickly than previously possible.

The test is for use on Polymedco's PathFast analyzer with whole-blood and plasma specimens. Results should be used with other diagnostic information such as electrocardiogram, clinical findings, and patient symptoms to help diagnose heart attacks, the firm said.

In collaboration with healthcare systems, payors, providers, and reference laboratories, Polymedco develops screening and early detection programs to identify life-threatening diseases.