Quidel gets amended FDA EUA for Covid-19 antigen test device
The US Food and Drug Administration (FDA) has expanded emergency use authorization (EUA) to market Quidel’s rapid Covid-19 antigen test device, Sofia Q. The test…
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US regulator warns against use of Innova SARS-CoV-2 test
The US Food and Drug Administration (FDA) has warned the public against the use of Innova Medical Group’s SARS-CoV-2 Antigen Rapid Qualitative Test for diagnostic…
FDA approves Medtronic’s Vanta spinal cord stimulator
Medtronic has secured approval from the US Food and Drug Administration (FDA) for its Vanta device, a recharge-free implantable neurostimulator…
US FDA approves CyMedica’s Intellihab system to treat knee osteoarthritis
CyMedica Orthopedics has secured approval from the US Food and Drug Administration (FDA) for its Intellihab system, a non-invasive modality…
Navigation Sciences starts clinical feasibility trial of NaviSci System
Navigation Sciences has commenced the first-in-human clinical feasibility trial of its NaviSci System, which is used for tissue-conserving removal of…
Promega’s SARS-CoV-2 immunoassay obtains CE mark
Promega’s Lumit Dx SARS-CoV-2 Immunoassay has obtained CE mark for qualitative in vitro diagnostic detection of antibodies to SARS-CoV-2 in…
