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Trinity Biotech PLC

www.trinitybiotech.com

Latest From Trinity Biotech PLC

US FDA Willing And Ready To Approve Novel Cardiac Troponin Assays

Rumors that FDA has raised the bar too high for clearing cardiac troponin assays to predict myocardial infarction "are not true," a device center reviewer said at an agency workshop. FDA is open to novel tests and wants industry to give it direction on clinically meaningful cut-off levels of troponin for assays. Also, FDA issued a safety alert on consumer overuse of Biotin (Vitamin B7) for aesthetic purposes, which can interfere with the results of the assays.

In Vitro Diagnostics Research and Development Strategies

Cardiac Troponin Assays Will Get US FDA Attention At November Workshop

Troponin assays are routine tools for diagnosing heart attacks, but there have been challenges on the regulatory front, as testing standards evolve and technology rapidly improves. The agency has called a public meeting for late November to discuss scientific and regulatory challenges for troponin assays and more efficient development strategies.

Regulation Innovation

OUS Approvals: Edwards And Trinity Lead Spring Surge

With 50 non-US approvals recorded by Medtech Insight in March, there were almost twice as many medical device approvals outside the US last month as in February and more than any month in the last year. Cardiovascular devices were in the lead, together with IVDs, and highlights on March's list include several new peripheral vascular technologies, including PQ Bypass' peripheral bypass system.

Approvals Innovation

Trinity Pulls 510(k) For Troponin Point-Of-Care Test

Trinity Biotech said US FDA may be expecting its point-of-care troponin assay to match the performance of laboratory-based systems and, as a result, it is withdrawing it its pending 510(k) submission. The firm said FDA has expressed concerns that the company's system has not met the agency's sensitivity threshold and is unable to operate in a wide enough temperature range.

Medical Device Diagnostics
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