Chinese approval for Diagnostic Hybrids' D3 Ultra respiratory virus test
This article was originally published in Clinica
Executive Summary
The Chinese state FDA (SFDA) has approved Diagnostic Hybrids' D3 Ultra DFA (direct fluorescence assay) respiratory virus screening and ID kit. The test can identify influenza A and B, parainfluenza 1, 2 and 3, respiratory syncytial virus and adenovirus. It can test patient specimens directly, providing results in 15 minutes, or cell culture, in combination with the firm's R-Mix and R-Mix Too Mixed FreshCells cell culture systems, giving results in 24-48 hours. Diagnostic Hybrids (Athens, Ohio), which became a subsidiary of Quidel after its acquisition in February, claims that the product is a market leader in the US clinical virology testing market. It was first cleared by the FDA in January 2006.
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.