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Clinical laboratory staff and healthcare providers should consider confirming results obtained using BD’s test with an alternate authorized test, the FDA said. Read More
The blood test will detect both immunoglobulin M (IgM) antibodies — the first antibodies the body makes when it fights a new infection — and immunoglobulin G (IgG) antibodies, which show up later. Read More
The funding supports Inovio’s large-scale production of devices to deliver potentially hundreds of millions of doses of its vaccine next year, the company said. Read More
Success in the study will be measured by the pump’s ability to maintain adequate hemodynamic support and a low rate of major device-related adverse events, Abiomed said. Read More
The Medical Device Innovation Consortium (MDIC) is asking for feedback on its new draft framework for using real-world evidence (RWE) in the development and clearance of in-vitro diagnostics (IVDs). Read More
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