The US Food and Drug Administration in January modified existing 510(k) clearances for several firms, including Becton Dickinson and Roche, while it granted new clearances for diagnostic instruments and assays from Medica, Selux Diagnostics, and others, according to the agency website.
Roche announced on Monday that its Cobas Pure Integrated Solutions instrument has received 510(k) clearance from the US Food and Drug Administration.
Despite significant and stunning advances in vaccine technology, the COVID-19 global pandemic is not over. A key challenge in limiting the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is identifying infected individuals.
Alamar Biosciences said on Wednesday that it has closed an $80 million Series B financing round, bringing its total funding to $110 million.
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