FDA clears SQI's diagnostic platform and rheumatoid arthritis test
This article was originally published in Clinica
Executive Summary
Two new products from SQI Diagnostics have received 510(k) clearance from the US FDA: the automated SQiDworks diagnostic platform; and the multiplexed IgXPLEX rheumatoid arthritis (RA) assay. The test simultaneously measures multiple biomarkers involved in the disease, including rheumatoid factor (RF)-IgA, RF-IgM and anti-cyclic citrullinated peptide (CCP)-IgG. The new platform is a "significant advancement" from current standards of biomarker testing, which can be "inefficient and labour intensive", the Toronto, Canada-based company claims. SQI plans to release other IgXPLEX test panels in 2010, including those for irritable bowel disease, coeliac disease and lupus. The company CE marked the SQiDworks platform and its QuantiSpot RA assay for sale in Europe in February 2009.
You may also be interested in...
What are the hottest innovations from Israel?
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.
EuroPCR: St Jude and Philips talk up rival intravascular imaging techs
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.
EuroPCR: Medtronic's drug-coated balloon keeps rising
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.