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Revvity's Euroimmun Expanding MDx Menu for Fungal Infections, Drug Resistances
The company aims to soon launch two tests to aid the treatment of dermatomycosis and is developing other tests for healthcare ...
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Roche Enters New Market With Launch of STI Molecular, Point-of-Care Tests
The PCR-based point-of-care assays, which return results within 20 minutes, have received regulatory approval from the US Food and Drug Administration earlier this year.
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Roche Enters New Market With Launch of Point-of-Care Molecular STI Tests
The PCR-based point-of-care assays, which return results within 20 minutes, have received regulatory approval from the US Food and Drug Administration earlier this year.
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Staff Cuts at FDA CDRH Could Slow Medical Device Reviews, Stakeholders Warn
In particular, the cuts could hurt the FDA's efforts to scale up its expertise and review capabilities in emerging areas like digital- and AI-based devices.