Trinity submits CLIA application for TRIstat HbA1c test
This article was originally published in Clinica
Trinity Biotech has applied to the US FDA for a CLIA waiver for its TRIstat point-of-care HbA1c blood test. The test measures glycated haemoglobin, an indicator of diabetic patients' average blood sugar control over the past two to three months. It provides results "in minutes" and does not require refrigeration, unlike other available HbA1c tests, Bray, Ireland-based Trinity says. TRIstat received FDA 510(k) clearance in December 2007, but CLIA-waived status would mean it could be used by non-laboratory trained physicians in CLIA-certified labs.
You may also be interested in...
Israel is well-known as a medtech hot-spot, with a focus on academic research and strong government support helping the country punch well above its weight when it comes to innovative devices.
St Jude Medical had a heavy focus on its intravascular imaging offering at this year’s EuroPCR meeting, presenting data supporting its optical coherence tomography (OCT) technology. OCT provides intravascular images to help assess culprit lesions, which can improve stent selection and deployment, according to St Jude.
A big topic at this year’s EuroPCR, held in Paris on 19-22 May, was drug-coated balloons (DCBs). One of the leaders in the field, Medtronic, presented positive data from two studies of its IN.PACT Admiral balloon, which could support an expanded indication for the device.